01. ATT 5. SOP for Contractor Cleaning.pdf

Office of Research Support & Compliance

Standard Operating Procedure for Contractor Cleaning and Disinfection of NIH Intramural Aseptic Processing and Testing Facilities

Emmanuel Woode

Nicole Lim Virginia Guptill

1. Purpose

The Purpose of this Standard Operating Procedure (SOP) is to describe the procedures for cleaning and disinfecting intramural Aseptic Processing and Testing Facilities at the National Institutes of Health (NIH) Bethesda Campus.

2. Scope

2.1. This SOP applies to the scheduled and ad hoc cleaning and disinfection of NIH Intramural Aseptic Production and Testing Facilities to ensure that the area bioburden is at acceptable levels for the aseptic preparation, processing, and testing of products for human use.

2.2. This SOP applies to contractors or NIH personnel performing facility cleaning and disinfection activity at NIH intramural Aseptic Processing and Testing Facility.

2.3. This SOP applies to NIH intramural Aseptic Production and Testing Facility Management, Quality Assurance and other personnel responsible for facility oversight.

2.4. This SOP applies to the Office of Research Support and Compliance (ORSC) personnel managing and supporting facility cleaning activities.

2.5. Cleaning of the internal surface of Primary Engineering Controls (PECs) is out of scope of this SOP as those shall be managed by facility-specific SOPs.

3. Responsibilities

3.1. Cleaning Contractor:

3.1.1. Cleaning Contractor Management is responsible for ensuring that all staff members receive a combination of training, education, and experience necessary to execute the cleaning task here at the NIH.

3.1.2. The cleaning contractor is responsible for generating and disseminating Cleaning Schedules on the ORSC Cleaning SharePoint Site.

3.1.3. Cleaning contractors are responsible for following this SOP, related documents, and adhering to all contractual agreements during Cleaning and Disinfecting activities within NIH Intramural Aseptic Processing and Testing Facilities.

3.1.4. Responsible for ensuring that all NIH cleaning competencies have been demonstrated and reported on forms ORSC-APF-001G (Cleaning Contractor Gowning Qualification Checklist) and ORSC-APF-001H (Cleaning and Disinfection Qualification Checklist) prior to cleaning any NIH facility.

3.1.5. Responsible for ensuring that all Contractor-Level trainings and certification are up-to-date before cleaning any NIH facility.

3.1.6. Responsible for ensuring that all personnel perform read and understanding training on this SOP and related documents during initial personnel onboarding and following

Disinfection of NIH Intramural Aseptic Processing and Testing Facilities

SOP revisions.

3.1.7. Responsible for training personnel to execute this SOP in the field after the read and understand training.

3.1.8. Responsible for ensuring that adequate staff members are present to execute the cleaning task at all times.

3.1.9. Responsible for responding to all cleaning-related enquiries from end users.

3.1.10. Responsible for participating in cleaning-related investigations and deviations.

3.1.11. Responsible for completing Form ORSC-APF-001F (Cleaning Event Log) during ongoing cleaning investigations in a timely manner.

3.1.12. Responsible for ensuring that cleaning documentations are completed according to applicable Good Documentation Practices.

3.1.13. Responsible for requesting additional cleaning logbooks before existing logs runout.

3.1.14. Responsible for performing and documenting post-cleaning inspections.

3.1.15. Responsible for disposing spent cleaning agents in dedicated waste receptacles.

3.1.16. Responsible for ensuring that adequate cleaning consumable exists for daily operation.

3.1.17. Responsible for alerting ORSC when cleaning tools and consumables need to be replaced or replenished.

3.2. ORSC Task Leader/Contracting Officer Representative(COR)

3.2.1. Responsible for revising this SOP and related documents to reflect current information and needs of facilities.

3.2.2. Responsible for administering quiz to cleaning contractors following Read and understand training on this SOP.

3.2.3. Responsible for coordinating initial and ongoing gowning qualifications between contractors and end users.

3.2.4. Responsible for coordinating safety training, badging, and facility access for all contractors.

3.2.5. Responsible for maintaining a current list of cleaning contractors and ensuring that each contractor is sufficiently trained to perform their task.

3.2.6. Responsible for ensuring that all end user enquiries have been satisfactorily addressed by the contractor.

3.2.7. Responsible for working with Facility Management and Quality Assurance to develop and implement Cleaning Workflow Diagrams (CWDs) for new facilities before an Environmental Monitoring Performance Qualification (EMPQ) is completed.

3.2.8. Responsible for working with facilities to establish or revise cleaning times, frequency, and levels at all stages of facility lifecycle.

3.2.9. Responsible for working with cleaning contractor and end users to investigate and resolve issues cleaning-related issues.

3.2.10. Responsible for generating and issuing Cleaning Logbooks to facilities.

3.2.11. Responsible for preforming random cleaning audits and communicating audit findings to end user and contractor for resolution and continuous improvement.

3.2.12. Responsible for ensuring that cleaning tool and consumables are adequately stocked.

3.2.13. Responsible for tracking and trending cleaning-related events and ensuring that associated Corrective and Preventative Actions (CAPAs) are implemented and closed.

3.3. Facility Management and QA:

3.3.1. Responsible for working with ORSC and SMEs to create CWDs prior to EMPQ for new facilities.

3.3.2. Responsible for preparing the rooms for cleaning including covering sensitive equipment and relocating equipment before the cleaning process.

3.3.3. Responsible for performing post-cleaning inspections and logbook reviews (cleaning and solution preparation) before processing and reporting cleaning related events on the ORSC SharePoint site using Form ORSC-APF-001F within 24 hours of discovery.

3.3.4. Responsible for defining additional cleaning requirements per facility needs and recommending updates to applicable Cleaning logbooks using Form ORSC-APF-001B (Facility Cleaning Change Request).

3.3.5. Responsible for closure and archival of Cleaning Logbooks.

3.3.6. Responsible for performing routine cleaning audits and communicating audit findings to ORSC and contractor for resolution and continuous improvement.

4. Procedure

4.1. Cleaning Schedule Management

4.1.1. The contractor creates and publishes a Monthly Schedule using information from the Master

Facility Cleaning Schedule (ORSC-APF-001A).

4.1.1.1. The schedule shall be published on the ORSC SharePoint site before the first day of the next month.

4.1.2. Facility management or designee shall submit Form ORSC-APF-001B on the Cleaning SharePoint site to request changes to the routine cleaning schedule, at least two weeks, in advance when possible.

4.1.3. The ORSC task leader shall work with the cleaning contractor to approve or disapprove request.

4.1.4. The contractor shall modify the Monthly Cleaning schedule on weekly basis to reflect special cleaning requests and shall publish the revised schedule on the ORSC SharePoint site.

4.2. Pre-Cleaning Room Setup

4.2.1. Facility management shall ensure that rooms are appropriately setup for cleaning and that the cleaning contractors are duly notified of special conditions in the room.

4.3. Step 1: Determine assigned facilities by referencing the most up-to-date schedule on the ORSC Cleaning SharePoint site.

4.3.1. Two types of cleaning shall be performed:

4.3.1.1. Routine Cleaning: This includes all cleaning performed according to the Monthly

Cleaning Schedule.

4.3.1.2. Special Cleaning: This includes non-routine cleanings requested through a Facility

Cleaning Change Request (Form ORSC-APF-001B).

4.3.2. The cleaning contractor shall select the applicable Cleaning Type at step 1 (one) of the cleaning log.

4.3.3. The cleaning contractor shall populate the cleaning date at step 1 (one) of the cleaning log.

4.3.3.1. The acceptable date format shall be DDMMYYYY or DDMMYY. Example a cleaning performed on April 4, 2019 will be written as 04Apr2019 or 4Apr19.

4.4. Step 2: Pre-use consumables and tools retrieval and cleaning:

4.4.1. Cleaning consumables retrieval and pre-use cleaning:

4.4.1.1. All cleaning consumables shall be retrieved from the 12th Floor Cage located in Building 10.

4.4.1.2. Soap-wash, dry hands, and put on gloves before retrieving cleaning consumables.

4.4.1.3. Remove applicable consumable(s) from cardboard boxes and wipe all outer wrappings with 70% sIPA.

4.4.1.4. Place the wiped consumable on the transport cart if transporting consumable within building 10.

4.4.1.4.1. Place consumables in a transport bin when transporting consumable outside of NIH Building 10.

4.4.1.4.2. Wipe the interior of the transport bin using 70% sIPA and place it on a transport cart.

4.4.2. Cleaning tool retrieval and pre-use cleaning:

4.4.2.1. Ensure that the HEPA Vacuum filter has been replaced according to the quarterly replacement schedule.

4.4.2.2. If not, replace and document the activity in the vacuum cleaner filter replacement logbook containing Form ORSC-APF-001D (Vacuum Cleaner HEPA Filter Replacement Log).

Note: Do not vacuum the I-IVAU facility during routine scheduled cleaning activity.

4.4.2.3. Retrieve and wipe down the body of the vacuum cleaner and associated tools using 70% sIPA.

4.4.2.4. Place wiped items on the transport cart.

4.4.2.5. Using 70% sIPA wipe mop handles and mop buckets.

4.4.2.6. Place wiped items on the transport cart if being transported.

4.4.3. Initial and date the cleaning logbook after performing the pre-use consumable and tool cleaning process.

Note: In some cases, mop buckets and handles may reside in dedicated space within the facility and not in a central storage. In such cases, the tools shall be wiped at the storage location within the facility before use.

4.5. Step 3: Facility Entry

4.5.1. While outside the facility, thoroughly wipe the exterior surfaces of transport bins, mop handles, and cleaning buckets, and any other cleaning tool using 70% sIPA before transporting it into a facility.

4.5.2. Follow facility specific gowning procedures to enter the facility.

4.5.3. Whiles in the facility remove and discard the outer wrappings of all consumables in a cleaning contractor waste bags.

Note: Do not remove the inner wrappings of cleaning consumables unless you are in the area designated for preparing cleaning solution.

4.5.4. Initial and date the cleaning logbook after performing the facility entry step.

4.6. Step 4: Select the applicable Cleaning Level as indicated on the cleaning schedule.

4.6.1. Four levels of cleanings shall be employed when cleaning and disinfecting NIH Intramural Aseptic Processing and Testing Facilities as defined below:

4.6.1.1. Level 1 Cleaning: This includes:

4.6.1.1.1. HEPA vacuuming of floors

Note: Do not vacuum the I-IVAU facility during routine scheduled cleaning activity.

4.6.1.1.2. Hand wiping of surfaces specified in the cleaning logbook using the phenolic agent in rotation.

4.6.1.1.3. Removal of the disinfectant from hand-wiped equipment using 70% sIPA after the allotted contact times.

4.6.1.1.4. Removal of the disinfectant from the hand-wiped counter tops and non-equipment surfaces using DECON Clean after contact times.

4.6.1.1.5. Floor-moping (including floors in cart pass-through) using the scheduled cleaning and disinfecting agent.

4.6.1.2. Level 2 Cleaning: This includes:

4.6.1.2.1. HEPA vacuuming of floors

Note: Do not mop HEPA FILTER Screens during the Ceiling Moping Process instead, mop gently around them.

4.6.1.2.2. Moping of ceiling [including Light fixtures] walls, doors, and glass windows using scheduled agent.

4.6.1.2.3. Change of mop head followed by moping of cart pass-through if applicable.

4.6.1.2.4. Hand wiping of surfaces defined in the cleaning logbook using the phenolic agent in rotation where applicable.

4.6.1.2.5. Removal of the disinfectant from hand-wiped equipment using 70% sIPA after the allotted contact times.

4.6.1.2.6. Removal of the disinfectant from hand-wiped counter tops and non-equipment surfaces using DECON Clean after contact times.

4.6.1.2.7. Floor-moping using the scheduled cleaning and disinfecting agent.

4.6.1.3. Level 3 Cleaning: This includes:

4.6.1.3.1. HEPA vacuuming of floors

Note: Do not vacuum the I-IVAU facility during routine scheduled cleaning activity.

4.6.1.3.2. Moping of ceiling [including Light fixtures], walls, doors, and glass windows using the sporicidal agent.

4.6.1.3.3. Change of mop head followed by moping of cart pass-through using sporicidal agent where applicable.

4.6.1.3.4. Hand wiping of defined surfaces in the cleaning logbook using the sporicidal agent.

4.6.1.3.5. Floor-moping using the sporicidal agent.

4.6.1.3.6. Re-execution of steps 4.6.1.3.2, 4.6.1.3.3, 4.6.1.3.4, and 4.6.1.3.5 using the scheduled phenolic agent in rotation.

4.6.1.3.7. Removal of the residual cleaning agent from ceiling, walls, doors, glass windows, and cart pass-through using DECON Clean.

4.6.1.3.8. Removal of the disinfectant from hand-wiped equipment using 70% sIPA.

4.6.1.3.9. Removal of the disinfectant from the hand-wiped counter tops and non-equipment surface using DECON Clean after contact times.

4.6.1.3.10. Floor-moping using the scheduled phenolic agent.

4.6.1.4. Level 4 Cleaning: This Includes:

4.6.1.4.1. HEPA vacuuming floors

Note: Do not vacuum the I-IVAU facility during routine scheduled cleaning activity.

4.6.1.4.2. Moping of ceiling [including Light fixtures], walls, doors, and glass windows using the phenolic agent in rotation

4.6.1.4.3. Change of mop head followed by moping of cart pass-through using the phenolic agent in rotation if applicable.

4.6.1.4.4. Hand wiping of defined surfaces in the cleaning logbook using the phenolic agent in rotation.

4.6.1.4.5. Floor-moping using the phenolic agent in rotation.

4.6.1.4.6. The first re-execution of Steps 4.6.1.4.2, 4.6.1.4.3, 4.6.1.4.4, and 4.6.1.4.5 using the sporicidal agent.

4.6.1.4.7. A final re-execution of steps 4.6.1.4.2, 4.6.1.4.3, 4.6.1.4.4, and 4.6.1.4.5 using the unscheduled phenolic agent.

4.6.2. Initial and date the cleaning logbook after selecting the cleaning level.

4.7. Step 5: Cleaning Solution Preparation

4.7.1. Hand Bucket Preparation:

4.7.1.1. While in the facility, follow the applicable gowning requirements and proceed to the assigned solution preparation area specified in the cleaning logbook.

4.7.1.2. Don safety glasses and a pair of gloves - if not already donned.

4.7.1.3. Remove the inner wrappings from the cleaning consumable and discard the wrappings into a cleaning contractor waste bag.

4.7.1.4. Record the Cleaning date, cleaning agent, cleaning agent lot number, and expiration date in the Cleaning Solution Preparation Logbook (Form ORSC-APF- 001E).

4.7.1.5. When preparing LpH and Vesphene hand wiping buckets, remove and decant the entire content of the pocket of concentrate disinfectant into to the premeasured water in the gallon.

4.7.1.6. Invert the gallon at least three (3) times to ensure that the content is uniformly mixed.

4.7.1.7. Pour the entire content of the freshly made LPH or Vesphene into the hand wiping bucket.

4.7.1.8. When preparing Peridox hand buckets, pour the entire content of the agent directly into the hand bucket.

4.7.1.9. Soak the approved cleanroom wipes in the hand bucket

4.7.1.10. Prepare a new hand bucket when cleaning agent levels are low, when moving between zones and when the content of the hand bucket is visible dirty.

4.7.1.11. Alternatively, surfaces may be hand-wiped using cleanroom wipes sprayed with the applicable cleaning agent.

4.7.1.12. Cleanroom wipes may also prepared by pre-soaking the wipes in applicable cleaning solution and storing them in the primary packaging of the wipes or in sterile bucket liners for one-time use during the hand-wiping process.

4.7.1.13. Indicate the total number of gallons used for the entire hand wiping operation within the applicable zone in the Cleaning Solution Preparation Logbook.

4.7.1.14. Initial and date the Cleaning Solution Preparation logbook after preparing last bucket of that specific cleaning agent.

4.7.1.15. The cleaning contractor supervisor or designee shall review the solution preparation step in the solution preparation logbook.

4.7.1.16. The end-user shall review the cleaning preparation log as part the cleaning document review before processing each day.

4.7.2. Mop Bucket Preparation:

4.7.2.1. Follow steps 4.7.1.1 through 4.7.1.6 to prepare Vesphene and LPH solutions for mop buckets. Paradox is ready to use and does not need to be mixed.

4.7.2.2. Line the cleaning bucket with a sterile bucket liner.

4.7.2.3. Pour the entire gallon of the cleaning agent into the lined mop bucket.

4.7.2.4. Remove the mop head from the primary wrappings and attach it to the mop frame.

4.7.2.5. Submerge the mop into the prepared bucket.

4.7.3. Cleaning Agent Expiration

4.7.3.1. Cleaning agents shall be completely used once opened.

4.7.3.2. All opened but unused cleaning agents shall be discarded following cleaning activities within a given facility.

Note: Do not share open disinfectant between facilities.

4.7.3.3. If unopened cleaning agents are to be transported out of a facility for use in another facility, it must remain in its primary wrappings and must be thoroughly wiped per section 4.4 of this SOP.

4.8. Step 6: Pre-cleaning Inspection.

4.8.1. Inspect and document any abnormal room or equipment condition in the comment section of the Cleaning logbook Form. Examples of such conditions may include but is not limited to: DO NOT ENTER signage that prevents execution of task , ongoing construction that prevents execution of task, BSC Blower in off position, Audible Alarms, unusual door swings, access issues, chemical leaks, floods, and opened doors of controlled temperature units (fridge, freezer, and incubator).

4.8.2. Call the facility contact person(s) posted on the facility entrance, if the existing condition impedes your work in the area or if condition require an immediate maintenance intervention.

4.8.3. Note all pre-cleaning observations in the applicable cleaning logbook.

4.8.4. Initial and date the cleaning logbook after performing the Pre-Cleaning Inspection Step.

4.9. Step 7: Execute the cleaning steps applicable to each Cleaning Level as indicated in step 4.10, 4.11, and 4.12 below.

4.10. Cleaning Level 1

4.10.1. Vacuuming of Floors:

4.10.1.1. Select the room(s) being cleaned and indicate the vacuuming start time and performer initial on the cleaning log.

4.10.1.2. Using overlapping strokes, vacuum the floors from the cleanest side to the dirtiest side of the room per the order specified in the applicable Cleaning

Disinfection of NIH Intramural Aseptic Processing and Testing Facilities

Workflow Diagram (CWD).

4.10.1.3. Reference Section 7 for applicable CWDs.

4.10.1.4. Ensure that all floors are vacuumed where possible.

4.10.1.5. Indicate the vacuuming end time and the performer initial and activity date in the applicable cleaning logbook after the vacuuming step.

4.10.2. Hand wiping of Non-structural Cleanroom Surfaces:

4.10.2.1. Non-structural surfaces include all cleanroom surfaces other than ceiling, walls and floors.

Note: non-structural surfaces such as casework, shelving, raceways, and unobstructed surfaces may be cleaned with easy reach tool.

4.10.2.2. Cleaning and disinfection of these surfaces shall be accomplished through hand wiping.

4.10.2.3. Cleaning logs shall be customized by ORSC to reflect surfaces requiring hand wiping for each zone within a facility.

4.10.2.4. Hand wiping shall be performed with hand wipes prepared in buckets at step

4.7 based on the disinfectant rotation schedule (reference Attachment 2).

Note: Some non-structural surfaces may require hand wiping with %70 sIPA only. Others surfaces shall not be wiped with Peridox. All such surfaces shall be clearly labeled on the applicable cleaning log as (sIPA only) or (no Peridox).

4.10.2.5. Indicate the hand wipe start time and performer initial in the applicable cleaning logbook.

4.10.2.6. Using unidirectional overlapping strokes, hand wipe the non-structural surface as specified in the cleaning logbook and by turning the wipe to a new side after each stroke until all eight faces have been used.

4.10.2.7. The eight-fold wipe technique should be achieved as shown below and wipes discarded after using all eight faces.

Figure 1: Eight-fold Wipe Technique Front Side Back Side

4.10.2.8. During hand wiping, ensure wipes are saturated but not dripping and that surfaces are adequately wetted, and the desired contact times (reference Attachment 1) are observed before adding the next disinfectant.

4.10.2.9. Check the boxes in the cleaning logbook after each equipment is cleaned.

4.10.2.10. Enter the end time of the hand wiping operation on the cleaning log.

4.10.3. Cleaning agent removal:

4.10.3.1. Using %70 sIPA wipes remove the applied cleaning agent from all hand wiped surfaces after the allotted contact times.

4.10.3.2. Using DECON Clean remove applied agents from counter tops and other non-equipment surfaces.

4.10.3.3. Document the start and end times of the cleaning agent removal step on the cleaning log.

4.10.4. Hand-wiping of select non-structural surfaces:

4.10.4.1. Hand wiping of exterior of incubators, refrigerators, freezers, and biosafety cabinets and other hoods:

4.10.4.1.1. Using unidirectional and overlapping strokes, wipe the equipment from top to bottom.

4.10.4.1.2. Use step stools or cleanroom ladders to reach high points and tops of these equipment.

Note: Do not wipe/clean screens or displays of controlled temperature unit as this is the responsibility of end-users.

4.10.4.2. Door handles and touchpoints:

4.10.4.2.1. Saturate doors handles with adequate cleaning agent and ensure the assigned contact times are observed.

4.10.4.3. Hand wiping of material pass-through boxes:

4.10.4.3.1. When hand wiping material pass-through boxes, open the pass-through boxes from the cleanest side (the side with better quality air classification) of the room and hand wipe the box in the following order: roof, sides, and floor using the applicable cleaning agent.

4.10.4.3.2. Where pass-through boxes are housed in rooms of the same ISO classification the cleaning logbook shall clearly indicate which side to open.

4.10.4.3.3. Wipe the exterior of the pass-through using the scheduled agent ensuring that the handles are adequately saturated with cleaning agents.

4.10.4.4. Hand wiping room parameter sensors:

4.10.4.4.1. Using dry lint free cleanroom wipes gently wipe all sensor casing after the ceiling and wall moping process.

4.10.4.5. Hand wiping recessed sprinkler heads:

4.10.4.5.1. Using lint free cleanroom wipes saturated with LPH or Vesphene gently wipe all recessed sprinkler heads during the ceiling moping process.

Note: Do not hand wipe recessed sprinkler heads with Peridox as this degrades the covers overtime.

Note: Do not hand wipe non-recessed sprinkler heads.

4.10.4.6. Hand wiping and decontamination of sinks:

4.10.4.6.1. Rinse sinks thoroughly to wash down any soap or residue within the sink basin.

4.10.4.6.2. Apply Disinfectant with cloth starting with fixtures, around the inside and outside surfaces of the sink, down into the drain.

Note: Do not pour disinfectant down the drain.

4.10.5. Floor Mopping

4.10.5.1. Two floor moping scenarios are approved:

4.10.5.1.1. Scenario 1 - Mop all the floors within one zone. Under this scenario, the same cleaning solution may be used for all the rooms in that zone and mop pads changed as needed.

4.10.5.1.2. Scenario 2 - Clean the ceiling, wall, and then floor within a single room in that order. Under this scenario, both the mop pad and cleaning solution must be discarded and replaced prior to starting the next room.

4.10.5.2. Wring the submerged mop head prepared at step 4.7.2, ensuring that the mop head is wet but not dripping.

4.10.5.3. Follow the applicable CWD and mop the floor using unidirectional overlapping stroke mop from the cleanest to the dirtiest side of the room.

4.10.5.4. Mop stroke shall leave a visible sheen on the surface being mopped. If sheen is not visible, or if the mop does not slide smoothly on the surface, rewet the mop.

4.10.5.5. Document the initials of the performer and the start and end times of the floor moping step in the cleaning log.

4.11. Cleaning Level 2

4.11.1. Vacuuming of Floors

4.11.1.1. Perform vacuum cleaning per step 4.10.1 of this SOP and document performer initials, the start and end times in the cleaning logbook.

4.11.2. Cleaning and Disinfecting Ceilings:

4.11.2.1. All ceilings shall be cleaned and disinfected after the floor-vacuuming step is completed.

4.11.2.2. Moping of ceiling shall be achieved using one of two scenarios:

4.11.2.2.1. Scenario 1 - Mop all the ceiling within one zone. Under this scenario, the same cleaning solution may be used for all the rooms in that zone and mop pads changed as needed.

4.11.2.2.2. Scenario 2 - Mop the ceiling, wall, and then floor, within a single room, in that order. Under this scenario, both the mop pad and cleaning solution must be discarded and replaced prior to starting the next room.

4.11.2.3. Wring the submerged mop head prepared at step 4.7.2 over the second mop bucket using the mop wringer ensuring that the mop head is wet but not dripping.

Note: Do not use your hands to wring the mop under any circumstance. Contact ORSC is you need additional wringers.

4.11.2.4. When cleaning and disinfecting ceilings, start with the most interior ceiling of the room as specified on the applicable CWD.

4.11.2.5. Mop the ceiling, performing overlapping strokes with the mop from innermost part to outermost part of the room in one direction and ensuring a visible sheen is observed during the moping process.

4.11.2.6. If sheen is not visible, or if the mop does not slide smoothly on the surface, rewet again, wring before continuing the mopping process.

4.11.2.7. During the moping process, ensure that the cleaning agent is not dripping from the ceiling.

4.11.2.8. If dripping is observed, stop the mopping process, re-submerge the mop in the clean agent and wring the mop over the dirty side of the bucket before continuing.

4.11.2.9. When moping around ceiling mounted-sensor, stop moping within one square foot of the sensor and hand-wipe up to but not including the sensor.

4.11.3. Cleaning and Disinfecting Walls, Doors, Windows:

4.11.3.1. All walls, doors, and windows shall be cleaned and disinfected by mopping after the ceiling moping step is completed.

4.11.3.2. Moping of walls, doors, and windows may be achieved using one of two scenarios:

4.11.3.2.1. Scenario 1 - Mop all the walls, doors, and windows within one zone. Under this scenario, the same cleaning solution may be used for all the rooms in that zone and mop pads changed as needed.

4.11.3.2.2. Scenario 2 - Mop the ceiling, wall, doors, windows, and then floor within a single room in that order. Under this scenario, both the mop pad and cleaning solution must be discarded and replaced prior to starting the next room.

4.11.3.3. When cleaning and disinfecting walls, doors, and windows start with the most interior wall or door of the room as specified on the applicable CWD. The typical pattern of cleaning is using overlapping mop strokes from top to bottom.

4.11.3.4. When moping walls pay attention to process equipment connections, environmental monitoring probes, electrical outlets or other wall obtrusion.

Mop up to one square foot of probes.

4.11.3.5. When moping walls, do not mop over exhaust or return grills. All return or exhaust grills shall be hand-wiped per section 4.10.2 of this SOP.

4.11.4. Cleaning and Disinfecting of Cart Pass-through:

4.11.4.1. All Cart Pass-through shall be cleaned and disinfected by mopping after the wall moping step is completed.

4.11.4.2. Change mop head before initiating cart pass-through cleaning.

4.11.4.3. When moping cart pass-through boxes, open the pass-through box from the cleanest side of the room and mop the box in the following order: ceiling, sides, and floor with the scheduled cleaning agent using unidirectional overlapping strokes.

4.11.4.4. Mop the exterior of the pass-through using the scheduled agent ensuring that the handles are adequately saturated with cleaning agent.

4.11.4.5. Document the initials of the performer as well the start and end times in the Cleaning logbook.

4.11.5. Hand wiping of Non-structural Cleanroom Surfaces:

4.11.5.1. Perform hand wiping operation per step 4.10.2 of this SOP, using the scheduled agent, and record start and end times as well as the performer initial in the cleaning logbook.

4.11.6. Cleaning agent removal:

4.11.6.1. Remove cleaning agents from hand-wiped surfaces per section 4.10.3

4.11.7. Floor Mopping

4.11.7.1. Mop the floors per step 4.10.5 of this SOP and document the activity in the cleaning logbook.

4.12. Step 7: Cleaning Level 3

4.12.1. Vacuuming of Floors

4.12.1.1. Perform vacuum cleaning as per step 4.10.1 of this SOP and document performer initials, the start and end times in the Cleaning Level 1 section of the cleaning log.

4.12.2. Cleaning and Disinfecting Ceilings:

4.12.2.1. Wring mop head submerged in Peridox and prepared at step 4.7.2, over the dirty side of the two bucket system ensuring that the mop head is wet but not dripping.

4.12.2.2. Mop the ceiling as described at step 4.11.2 of this SOP using Peridox.

4.12.3. Cleaning and Disinfecting Walls, Doors, Windows:

4.12.3.1. Mop the walls, doors, and windows as described at step 4.11.3 of this SOP using the Peridox prepared at step 4.7.2 ensuring that the mop head is wet but not dripping.

4.12.4. Cleaning and Disinfecting of Cart Pass-through:

4.12.4.1. Change the mop head before moping cart pass-through

4.12.4.2. Mop the Cart Pass-through described at step 4.11.4 of this SOP using the

Peridox prepared at step 4.7.2 ensuring that the mop head is wet but not dripping.

4.12.5. Hand wiping of Non-structural Cleanroom Surfaces:

4.12.5.1. Perform hand wiping operation per step 4.10.2 of this SOP using Peridox and record start and end times as well as the performer initial in the cleaning logbook.

4.12.6. Floor Mopping

4.12.6.1. Mop the floors per steps 4.10.5 of this SOP using Peridox and document the activity in the cleaning logbook.

4.12.7. Re-execute of steps 4.12.2., 4.12.3, 4.12.4, and 4.12.5 using the scheduled phenolic agent in rotation.

4.12.8. Removal of Cleaning Agents:

4.12.8.1. Using DECON Clean remove the cleaning agents from ceiling, walls, windows, doors, and cart pass-through.

4.12.8.2. Remove cleaning agents from hand-wiped surfaces per section 4.10.3.

4.12.9. Re-execute step 4.10.5 using the scheduled phenolic agent in rotation.

4.12.10. Document the initials of the performer as well the start and end times all the above activities in the cleaning logbook.

4.13. Step 7: Cleaning Level 4

4.13.1. Vacuuming of Floors

4.13.1.1. Perform vacuum cleaning as per step 4.10.1 of this SOP and document performer initials, the start and end times in the Cleaning Level 1 section of the cleaning log.

4.13.2. Cleaning and Disinfecting Ceilings:

4.13.2.1. Wring mop head submerged in scheduled phenolic agent prepared at step

4.7.2, over the dirty side of the two bucket system ensuring that the mop head is wet but not dripping.

4.13.2.2. Mop the ceiling as described at step 4.11.2 of this SOP using the scheduled phenolic agent.

4.13.3. Cleaning and Disinfecting Walls, Doors, Windows:

4.13.3.1. Mop the walls, doors, and windows as described at step 4.11.3 of this SOP using the scheduled phenolic agent prepared at step 4.7.2 ensuring that the mop head is wet but not dripping.

4.13.4. Cleaning and Disinfecting of Cart Pass-through:

4.13.4.1. Change the mop head before moping cart pass-through

4.13.4.2. Mop the Cart Pass-through described at step 4.11.4 of this SOP using the scheduled phenolic agent prepared at step 4.7.2 ensuring that the mop head is wet but not dripping.

4.13.5. Hand wiping of Non-structural Cleanroom Surfaces:

4.13.5.1. Perform hand wiping operation per step 4.10.2 of this SOP using the scheduled phenolic agent.

4.13.5.2. Record start and end times as well as the performer initial in the cleaning logbook.

4.13.6. Floor Mopping

4.13.6.1. Mop the floors per steps 4.10.5 of this SOP using the scheduled phenolic agent and document the activity in the cleaning logbook.

4.13.7. Re-execute of steps 4.13.2., 4.13.3, 4.13.4, 4.11.5, and 4.11.6 using Peridox.

4.13.8. Re-execute of steps 4.13.2., 4.13.3, 4.13.4, 4.11.5, and 4.11.6 using the unscheduled phenolic agent.

4.13.9. Document the initials of the performer as well the start and end times all the above activities in the cleaning logbook.

4.14. Post-Cleaning Activities

4.14.1. Cleaning Waste Removal

4.14.2. Do not dump spent cleaning agents down the drain, instead, decant the agent in dedicated cleaning waste receptacles provided by the Division of Environmental Protection (DEP).

4.14.3. Call the DEP at (301) 496-4710 for pick up when the container is full and ready for pick-up.

4.14.4. All opened cleaning agents shall be disposed of and not used for cleaning activities for another facility

4.14.5. All opened sterile wipes shall live in the facility and shall not be taken outside or used for another cleaning activity in another facility.

4.14.6. Remove and dispose all cleaning related wastes such as consumed wipes, empty gallons, wrappings, consumed disinfectant sachets, and spent mop heads using ORSC supplied waste bags.

4.14.7. Cleaning and Storage of tools

4.14.7.1. Hand wipe vacuum cleaner body and tools using 70% sIPA before storage.

4.14.7.2. Using 70%, sIPA, wipe mop handles, mop buckets, all other re-usable cleaning tools before storage in the designated storage area.

4.14.7.3. Ensure that mop handles hanging on racks and that mop buckets are inverted.

4.14.8. Post-Cleaning Inspection and Document Review by Cleaning Contractor:

4.14.8.1. The cleaning contractor supervisor or designee shall enter the zones shortly after cleaning and shall inspect the room per each criterion specified in the cleaning logbook.

4.14.8.2. At minimum the post-cleaning inspection review shall include inspection for puddles, wet surfaces, audible alarms, cleaning waste removal, facility and equipment door closure.

4.14.8.3. All data entered into the cleaning logbook shall comply with the principles of good documentation practice established by the facility being cleaned.

4.14.8.4. The cleaning contractor supervisor or designee shall report any cleaning related Quality Events on Form ORSC-APF-001F (Cleaning Event Log) by the end of the shift and shall drop the completed form in the facility-designated folder for quality events housed on the ORSC Cleaning SharePoint site.

4.14.8.5. The facility QA and ORSC shall receive notification of the event as soon as the document is dropped in the folder.

4.14.8.6. ORSC shall work with the contractor and/or Facility to resolve the issue or implement a CAPA.

4.14.8.7. Once the issue is resolved, ORSC shall relocate Form ORSC-APF-001F to the designated folder for resolved events.

4.14.9. Post-Cleaning Inspection and Document Review by NIH facility QA or designee:

4.14.9.1. Post cleaning inspection shall be performed by facility QA or designee before any processing is performed in the facility.

4.14.9.2. The inspector shall review the cleaning logbook before the next processing/production activity in the facility and shall report all cleaning gaps to ORSC by submitting Form ORSC-APF-001F on the ORSC Cleaning SharePoint site.

4.14.10. Handling of Post-Cleaning events by ORSC

4.14.10.1. The ORSC shall receive notification of cleaning quality events in outlook and shall work with the contractor and facility to resolve the issue and implement appropriate Corrective and Preventative Actions (CAPAs).

4.14.10.2. ORSC shall ensure that the cleaning event log ORSC-APF-001F is completed appropriately by all parties involved in the investigation before closure of the event.

4.15. Cleaning Record:

4.15.1.1. ORSC shall issue cleaning logbooks to each facility.

4.15.1.2. The logbooks shall contain facility-customized forms.

4.15.1.3. The logbooks shall be based on the zones within the facility. For example, if a facility has five zones they shall be issued five logbooks.

4.15.1.4. Facilities shall provide a storage location for each logbook.

4.15.1.5. All APFs shall request new logbooks from ORSC upon depletion of existing logbooks and shall be responsible for archival of the logbooks.

4.15.1.6. Logbooks shall be retired and archived by facilities following changes to the cleaning logs.

4.16. Cleaning Workflow Diagrams (CWD):

4.16.1.1. All facility Cleaning Workflow Diagrams are documented in Section 6 of this SOP and are subjected to change control.

4.16.1.2. CWDs are designed prior to Environmental Monitoring Performance Qualification (EMPQ) for each facility and shall depict the flow within zones and rooms.

4.17. Cleaning Audits

4.17.1. Facilities shall perform periodic cleaning audit using Form ORSC-APF-001H (Cleaning and Disinfection Qualification and Audit Checklist).

4.18. Cleaning Consumables Storage and Inventory Management

4.18.1. All cleaning consumables shall be stored in dedicated storage areas on pallets.

4.18.2. The cleaning contractor shall perform weekly inventory of the cleaning supplies and shall submit requisition forms to Materials Management and Environmental Services Department (MMESD) for restocking.

4.19. Training Requirements

4.19.1. Contractor Level Training:

4.19.1.1. Contractor shall submit all contractor-level staff training records to ORSC before initiating NIH Level training.

4.19.2. NIH Facility Gowning Qualification Process:

4.19.2.1. ORSC shall arrange facility-gowning training, qualification, and annual requalification for each contractor.

4.19.2.2. The facility shall perform the gowning training and shall document gowning competence of the contractor on Form ORSC-APF-001G: Cleaning Contractor Gowning Qualification Checklist.

4.19.2.3. In certain cases, fingertip samples shall be collected and tested as part of the qualification process. In such cases, a passing results will be required as part of the qualification process.

4.19.3. NIH Cleaning Qualification Process:

4.19.3.1. All contractors shall perform a read and understand training on this SOP after successfully completing NIH facility gowning assessment specified on ORSC Form

ORSC-APF-001H.

4.19.3.2. ORSC shall assess the level of understanding of the contractor by administering a quiz and shall document contractor competence on ORSC Form ORSC-APF- 001H: Cleaning and Disinfection Qualification Checklist.

4.19.3.3. An NIH Evaluator (ORSC, Facility QA or designee) shall asses the competence of personnel by checking the applicable box on Form ORSC-APF-001H.

4.19.3.4. In order to qualified, the contractor must successfully complete one (1) supervised and two (2) independent cleanings for each facility qualified for.

4.19.3.5. One of the independent cleanings shall be a Level 3 or 4 cleaning.

4.19.4. ORSC Management shall conclude to cleaning competency by reviewing and approving the checklist.

4.19.5. All Contractor-Level and NIH-level training records shall be current at all times and stored in dedicated folders within ORSC.

5. Definitions and Acronym

5.1. Aseptic Processing Facility: Facilities that produce drug and/or biologic products from human injection, implantation, ingestion, inhalation, or absorption. These include facilities where non-aseptic products are produced using aseptic practices.

5.2. Cleaning Tools: All re-usable equipment used in the cleaning process.

5.3. Cleaning Consumables: All single use materials used in the cleaning process.

5.4. I-IVAU: Interim Intravenous Admixture Unit

5.5. PEC (Primary Engineering Controls) - A device or zone that produces an ISO Class 5 environment for aseptic processing. The terminology may also be used for process closure or other technology, which excludes contaminants from the product.

6. Regulatory and Technical References

6.1. 21CFR 211.42(a)

6.2. 21CFR 211.42(c)

6.3. 21CFR 211.56(a)

6.1. 21CFR211.67(c)

6.2. PDA TR 70 2015

6.3. USP <797>

6.4. USP <800>

7. Related Documents

7.1. ORSC-APF-001A: Master Facility Cleaning Schedule

7.2. ORSC-APF-001B: Facility Cleaning Change Request

7.3. ORSC-APF-001C.01: 1B42 Cleaning Workflow Diagram

7.4. ORSC-APF-001C.02: 2C500 Cleaning Workflow Diagram

7.5. ORSC-APF-001C.03: 2J Cleaning Workflow Diagram

7.6. ORSC-APF-001C.04: 3T Cleaning Workflow Diagram

7.7. ORSC-APF-001C.05: 3W Cleaning Workflow Diagram

7.8. ORSC-APF-001C.06: TR-10B Cleaning Workflow Diagram

7.9. ORSC-APF-001C.08: PET Cleaning Workflow Diagram

7.10. ORSC-APF-001C.09: Building 50 Cleaning Workflow Diagram

7.11. ORSC-APF-001C.10: I-IVAU Non-Hazardous Cleaning Workflow Diagram

7.12. ORSC-APF-001C.11: I-IVAU CNC Cleaning Workflow Diagram

7.13. ORSC-APF-001C.12: I-IVAU Hazardous Cleaning Workflow Diagram

7.14. ORSC-APF-001D: Vacuum Cleaner HEPA Filter Replacement Log

7.15. ORSC-APF-001E.01: 1B42 Cleaning Solution Preparation Log

7.16. ORSC-APF-001E.02: 2J Cleaning Solution Preparation Log

7.17. ORSC-APF-001E.03: 3T Cleaning Solution Preparation Log

7.18. ORSC-APF-001E.04: 3W Cleaning Solution Preparation Log

7.19. ORSC-APF-001E.05: 2C500 Cleaning Solution Preparation Log

7.20. ORSC-APF-001E.06: TR-10B Cleaning Solution Preparation Log

7.21. ORSC-APF-001E.07: PET GMP Cleaning Solution Preparation Log

7.22. ORSC-APF-001E.08: PET SCA Cleaning Solution Preparation Log

7.23. ORSC-APF-001E.09: Building 50 Cleaning Solution Preparation Log

7.24. ORSC-APF-001E.10: I-IVAU Hazardous Cleaning Solution Preparation Log

7.25. ORSC-APF-001E.11: I-IVAU Non-Hazardous Cleaning Solution Preparation Log

7.26. ORSC-APF-001E.012: CNC Cleaning Solution Preparation Log

7.27. ORSC-APF-001F: Cleaning Event Log

7.28. ORSC- APF-001G: Cleaning Contractor Gowning Qualification Checklist

7.29. ORSC- APF-001H: Cleaning and Disinfection Qualification and Audit Checklist

7.30. ORSC- APF-001I: 1B42 Blue Zone Cleaning Log

7.31. ORSC-APF-001J.01: 2J Blue Zone Cleaning Log

7.32. ORSC-APF-001J.02: 2J Green Zone Cleaning Log

7.33. ORSC-APF-001J.03: 2J Red Zone Cleaning Log

7.34. ORSC-APF-001K: Building 50 Blue Zone Cleaning Log

7.35. ORSC-APF-001L.01: 3T Grey Zone Cleaning Log

7.36. ORSC-APF-001L.02: 3T Red Zone Cleaning Log

7.37. ORSC-APF-001L.03: 3T Blue Zone Cleaning Log

7.38. ORSC-APF-001M.01: 2C500 Blue Zone Cleaning Log

7.39. ORSC-APF-001M.02: 2C500 Red Zone Cleaning Log

7.40. ORSC-APF-001N.01: 3W Blue Zone Cleaning Log

7.41. ORSC-APF-001O.01: Trailer 10B Blue Zone Cleaning Log

7.42. ORSC-APF-001P.01: PET Blue Zone Cleaning Log

7.43. ORSC-APF-001P.02: PET Red Zone Cleaning Log

7.44. ORSC-APF-001P.03: PET Green Zone Cleaning Log

7.45. ORSC-APF-001P.04: PET Grey Zone Cleaning Log

7.46. ORSC-APF-001Q.01: I-IVAU Hazardous Zone Cleaning Log

7.47. ORSC-APF-001Q.02: I-IVAU Non-Hazardous Zone Cleaning Log

7.48. ORSC-APF-001Q.03: I-IVAU CNC Zone Cleaning Log

8. Cleaning Tools and Consumables

8.1. Cleaning Tools

Item Description Supplier Usage

Aluminum Extendable Universal Handle VWR Moping wep Duo Plus Frame VWR Moping

CE Bucket Trolley - Vileda Professional-FHP VWR Moping

Hand wiping Bucket VWR Hand-wiping

Transport Bins VWR Transport of consumable outside Building 10

Item Description Supplier Usage

Transport Carts VWR Transport of consumable up to and never beyond facility entry point

8.2. Cleaning Consumables

Item Description Supplier Usage

One Solution st LpH Sterile System VWR Cleaning and Disinfecting agent PeridoxRTU Sporicidal Disinfectant Cleaner VWR Cleaning and Disinfecting agent One Solution st Vesphene II Sterile System VWR Cleaning and Disinfecting agent.

DECON-CLEAN VWR

Removal of cleaning agents from ceiling, walls and floors

Wiper Prosat Sterile Pes 9X11 VWR Hand wiping activities requiring sIPA Wipes.

DECON-AHOL Sterile VWR Hand wiping activities requiring sIPA Wipes.

Sterile Suite FM Mop Benchmark Ceiling, Walls, Doors and Floor Moping.

Bucket liner B-7 Irradiated 31x19 VWR Lining mop buckets Wipe HSII Sterile12 X 12 VWR Used for hand wiping function.

9. Safety

9.1. heets for cleaning agents used. These will be provided in the area where the chemicals are stored.

9.2. Proper Personal Protective Equipment (PPE) must be worn when handling cleaning agents.

9.3. Wear proper gowning attire as required for the area where cleaning / sanitization is taking place including, but not limited to, safety glasses, goggles, face shields, and gloves.

9.4. Contractor approved fitted respirators shall be used when applying Peridox.

9.5. All chemicals are stored in accordance to OSHA, EPA, State, and Local regulations -safety precautions and safety data sheets provided in the area where the chemicals are stored.

9.6. Cleaning chemical containers and dispensers shall be used in a manner that minimizes the potential for harmful vapors and chemicals may not be stored in open containers.

9.7. For safety reasons all facilities shall be cleaned in pairs.

Disinfection of NIH Intramural Aseptic Processing and Testing Facilities

10. Revision History

Version Description of Change Reason for Change

1. Sections 4.6.1.2.3, 4.6.1.3.3, 4.6.1.4.3, 4.11.4.2, 4.12.4.1, and 4.13.4.1 amended to remove the need to change mop-bucket before moping cart pass-through.

2. Section 7.0 Changed cleaning logs from four (4) to three

(3) while in draft.

2J Cleaning logs from ORSC-APF-001J.01: 2J Grey Zone Cleaning Log, ORSC-APF-001J.02: 2J Red Zone Cleaning Log, ORSC-APF-001J.03: 2J Green Zone Cleaning Log, and ORSC-APF-001J.04: 2J Blue Zone Cleaning Log

Changed to:

ORSC-APF-001J.01: 2J Blue Zone Cleaning Log ORSC-APF-001J.02: 2J Green Zone Cleaning Log ORSC-APF-001J.03: 2J Red Zone Cleaning Log

Changed cleaning logs from seven (7) to three (3) while in draft. ORSC-APF-001Q.01: I-IVAU CNC Blue Zone Cleaning Log, ORSC-APF-001Q.02: I-IVAU Hazardous Blue Zone Cleaning Log, ORSC-APF-001Q.03: I-IVAU Hazardous Red Zone Cleaning Log, ORSC-APF-001Q.04: I-IVAU Hazardous Green Zone Cleaning Log, ORSC-APF-001Q.05: I-IVAU Non-Hazardous Blue Zone Cleaning Log, ORSC-APF- 001Q.06: I-IVAU Non-Hazardous Red Zone Cleaning Log, ORSC-APF-001Q.07: I-IVAU Non-Hazardous Green Zone Cleaning Log

Changed to:

ORSC-APF-001Q.01: -IVAU Hazardous Zone Cleaning Log ORSC-APF-001Q.02: I-IVAU Non-Hazardous Zone Cleaning Log ORSC-APF-001Q.03: I-IVAU CNC Zone Cleaning Log

3. Attachment 1 - DECON-Clean preparation was changed 1:128 simple mix

4. Attachment 2 Changed the notes tied to Changes every Monday

Changes every Sunday.

5. Form ORSC-APF-001B- Facility Cleaning Change Request changed from revision 1 to 2

1. To reduce cleaning chemical waste and duration of cleaning. New process involves changing mop head between wall and cart-pass-through cleaning.

2. As part of cleaning zone change to reduce cleaning chemical waste, paper work, and cleaning duration using risk assessment.

3. To reflect the updated information on dilution and solution preparation.

4.

the first day of the week.

5. To specify which level of change require ORSC management and Environmental Monitoring Advisory Committee Chair signatures. To relocate administrative changes to L1 Change.

11. Appendices

11.1. Attachment 1: Cleaning and Disinfecting Agents and their contact times

11.2. Attachment 2: Disinfectant Rotation Schedule

Disinfection of NIH Intramural Aseptic Processing and Testing Facilities

Doc. Number ORSC-APF-001 Version 01 Effective Date 01 November 19 Page Number Page 21 of 22

Attachment 1: Approved Cleaning and Disinfection Agents and Contact times

Disinfectant Preparation Properties

Peridox RTU 1 gallon st

Process Vesphene II st System

Process LpH st

Disinfection of NIH Intramural Aseptic Processing and Testing Facilities

Doc. Number ORSC-APF-001 Version 01 Effective Date 01 November 19 Page Number Page 22 of 22

Attachment 2: Disinfectant Rotation Schedule.

*Changes every Sunday

Disinfectant Rotation Schedule*

1st Week of each month Process Vesphene II st System

2nd Week of each month Process LpH st

3rd Week of each month Process Vesphene II st System

4th Week of each month Process LpH st

5th Week of each month Process Vesphene II st System

Once a month during Level 3 cleaning and Adhoc during Level 4 cleaning Peridox RTU 1 gallon st