Attachment 3 -SOP 119-15 IV Room Air and Surface Monitoring.pdf

IV Cleanroom Suite Microbiological Air and Surface Monitoring

SOP 119-15

Sheridan VA Medical Center Sheridan, WY 82801

Signatory Authority:

Chief of Pharmacy

Responsible Owner:

Quality Program Manager

1. PURPOSE AND AUTHORITY

Service Line(s):

Pharmacy

Effective Date:

April 1, 2025

Recertification Date:

March 31, 2030

a. The purpose of this standard operating procedure (SOP) is to establish procedures on the proper microbiological air and surface monitoring of the Sheridan VA Pharmacy IV cleanroom suite (ante-room and buffer rooms) and primary engineering controls (PECs). An effective microbiological air and surface monitoring program identifies environmental quality trends over time, identifies potential routes of contamination and allows for implementation of corrective actions to minimize the risk of Compounding Sterile Products (CSP) contamination. This SOP must be followed by all personnel who are involved in the compounding of CSPs.

b. This SOP sets forth mandatory procedures and processes to ensure compliance with VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Preparations, dated February 14, 2024, and the Revised United States Pharmacopeia General Chapter <797> “Pharmaceutical Compounding—Sterile Preparations, dated November 1, 2022.

2. PROCEDURES

a. General Monitoring Requirements

(1) Goals of the microbiological air and surface monitoring program are to determine whether contamination is present at unacceptable levels and to assess whether proper personnel practices are being followed, cleaning and disinfecting agents are effective, and environmental quality is maintained.

(2) The microbiological air and surface monitoring program will include:

(a) Viable impact volumetric airborne particulate sampling

(b) Surface sampling

(3) Microbiological air and surface monitoring must be conducted in all classified areas during dynamic operating conditions to confirm that the required environmental quality is maintained.

April 1, 2025 SOP 119-15

(4) Corrective action in response to any adverse findings is required to maintain the necessary environmental quality for preparation of CSPs.

(5) Data must also be reviewed following corrective actions to confirm that the actions taken have been effective in achieving the required microbiological air and surface quality levels.

(6) In addition to the specific sampling frequencies described, sampling must be performed in the following circumstances:

(a) In conjunction with the certification of new facilities and equipment.

(b) After any servicing of facilities or equipment.

(c) In response to identified problems (e.g., positive growth in sterility tests of CSPs).

(d) In response to identified trends (e.g., repeated positive gloved fingertip and thumb sampling results, failed media fill testing, or repeated observations of air or surface contamination.

(e) In response to changes that could impact the sterile compounding environment (e.g., change in cleaning agents).

b. Monitoring Air Quality for Viable Airborne Particles

(1) Volumetric active air sampling of all classified areas using an impaction device will be conducted in each classified area [e.g., ISO Class 5 PEC and ISO Class 7 rooms] during dynamic operating conditions.

(2) Air sampling will be completed at the time of recertification every 6 months by a CETA certifier.

(3) If levels measured during the viable air monitoring program exceed the levels in the table shown below for the ISO classification levels of the area sampled, the cause will be investigated and corrective action will be taken.

Action Levels for Viable Airborne Particle Air Sampling

ISO Class Air Sampling Action Levels [cfu per cubic meter (1000 liters) of air per plate] 5 >1 7 >10 8 >100

c. Monitoring Surfaces for Viable Particles

(1) Surface sampling is useful for evaluating facility cleaning and material handling procedures, work surface cleaning and disinfecting procedures, and personnel competency in work practices such as cleaning and disinfecting of component and/or vial surfaces.

(2) Surface sampling of all classified areas will be conducted monthly.

(3) Each classified area will be sampled, including the following:

(a) The interior of the PEC

(b) Staging or work area near the PEC

(c) Frequently touched surfaces

(4) Perform surface sampling as outlined below:

(a) Surface sampling will be performed at the end of a compounding activity or shift, but before the area has been cleaned and disinfected.

(b) Remove the cover from the media paddle. Using a rolling motion, firmly press the media surface onto the surface to be sampled, refer to the Monthly Microbiological Surface/Air Monitoring form for sampling locations.

(c) Cover each surface sampling device. Store media devices during incubation to prevent condensate from dropping onto the agar and affecting the accuracy of the CFU reading.

(d) After sampling, remove the residue from the surface using sterile 70% IPA.

(e) Incubate the media paddles at 30°-35° C for minimum of 2 days.

(f) Quality Program Manager, VISN contracted laboratory or designee with training documented in Simplify 797 will be responsible for examining the media paddles for growth and will record the total number of CFU per sample on the Monthly Viable Surface Sampling Log.

(g) Incubate the media paddles at 20°-25° C for a minimum of 5 additional days.

Record the total number of CFU per sample on the Monthly Viable Surface Sampling Log.

(5) If levels measured during surface sampling exceed the Action Levels in the table shown below, samples will be dispatched to VISN contracted laboratory, the cause will be investigated and corrective action will be taken.

Actions Levels for Surface Sampling

ISO Class Surface Sampling Action Levels (CFU/device or swab) 5 >3 7 >5 8 >50

d. Documentation

(1) The following will be documented and stored locally:

(a) All microbiological air and surface sampling tests and their results.

(b) All equipment records (e.g., calibration, verification, and maintenance reports).

(c) All certification reports, including corrective actions for any failure.

(2) Data collected in response to corrective actions will be reviewed to confirm that the actions taken have been effective in achieving the required microbiological air and surface quality levels.

3. ASSIGNMENT OF RESPONSIBILITIES

a. Chief of Pharmacy Service. The facility Chief of Pharmacy Service is responsible for:

(1) Designating a full-time pharmacist who is responsible for oversight of United States Pharmacopeial Convention (USP) compliance in the Pharmacy Department with USP <797>, USP<800>, The Joint Commission Standards, FDA requirements and VHA policies related to CSPs.

(2) Ensuring that appropriate policies and procedures are in place to support full compliance with all USP <797>, USP <800>, The Joint Commission standards, and VHA policies related to CSPs.

b. Quality Program Manager. The Quality Program Manager assigned by the facility Chief of Pharmacy Service is responsible for oversight of all CSP functions including:

(1) Ensuring that the decision to prepare CSPs in the medical facility pharmacy follows the VHA PBM decision-making hierarchy and associated guidance.

(2) Ensuring the pharmacy service has written procedures for compliance with the USP <797> and USP <800 standards.

(3) Ensuring the competency of Pharmacy personnel in the preparation and handling of CSPs as required by USP <797> and USP <800>.

(a) Maintaining environmental control of the sterile compounding areas, including:Collaborating with Biomedical/Engineering/Facilities Management services to ensure that Primary Engineering Controls (PEC) and Secondary Engineering Controls (SEC) are certified in accordance with USP <797> and USP <800> standards.

(b) Collaborating with the facility Quality Manager and the Chief, Infection Prevention and Control to develop a formal written CSP Safety and Quality Assurance (QA) Plan in accordance with USP <797> standards.

4. DEFINITIONS

a. Ante-room. An ISO Class 8 or cleaner room with fixed walls and doors where personnel hand hygiene, garbing procedures, and other activities that generate high particulate levels may be performed. The ante-room is the transition room between the unclassified area of the facility and the buffer room.

b. Buffer room. An ISO Class 7 or cleaner room with fixed walls and doors where PEC(s) that generate and maintain an ISO Class 5 environment are physically located.

The buffer room may only be accessed through the ante-room.

c. Colony-Forming Unit (CFU): A unit used in microbiology to estimate the number of viable bacteria or fungal cells in a sample.

d. Compounded Sterile Preparation. A Compounded Sterile Preparation (CSP) is a preparation intended to be sterile that is created by combining, diluting, pooling, or otherwise altering a drug product or bulk drug substance. A product produced by reconstituting a conventionally manufactured product for an individual patient strictly in accordance with the directions contained in the approved labeling provided by the product manufacturer is not considered a CSP within the standards of USP <797>.

e. Controlled Environment Testing Association (CETA) Controlled Applications Guides (CAGs). CETA CAGs define certification procedures to assess the PEC is performing and operating as designed to maintain a sterile environment for the preparation of CSPs.

f. Dynamic operating conditions: Conditions in the compounding area in which operating personnel are present and simulating or performing compounding. The conditions should reflect the largest number of personnel and highest complexity of compounding expected during routine operations as determined by the designated person(s).

g. International Organization for Standardization Class. An ISO class is an air quality classification of the ISO.

h. Microbial Contamination: Microbial contamination is the presence of microorganisms in or on an item.

i. Primary engineering control (PEC). A device or zone that provides an ISO Class 5 air quality environment for sterile compounding.

j. Secondary engineering control (SEC). The area where the PEC is placed (e.g., a cleanroom suite or a SCA). It incorporates specific design and operational parameters required to minimize the risk of contamination within the compounding area.

5. REFERENCES

a. Revised United States Pharmacopeia General Chapter <797> “Pharmaceutical Compounding—Sterile Preparations, dated November 1, 2022 available at:

www.usp.org

b. VHA Directive 1108.07, General Pharmacy Service Requirements, Amended December 6, 2024.

c. VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Preparations, dated February 14, 2024.

d. MCP 119-19, Compounded Sterile Preparations, dated April 30, 2021

6. REVIEW

This SOP will be reviewed annually to ensure it reflects current practices.

7. RECERTIFICATION

This SOP is scheduled for recertification on or before the last working day of March 2030. In the event of contradiction with national policy, the national policy supersedes and controls.

8. SIGNATORY AUTHORITY

NOTE: The signature remains valid until rescinded by an appropriate administrative action.

DISTRIBUTION: SOPs are available at:

https://dvagov.sharepoint.com/sites/VHASHEHCS/Local-Policy-Center/ http://www.usp.org/ https://www.va.gov/vhapublications/publications.cfm?pub=1 https://www.va.gov/vhapublications/publications.cfm?pub=1 https://www.va.gov/vhapublications/publications.cfm?pub=1 https://dvagov.sharepoint.com/sites/VHASHE/MCMs/Forms/AllItems.aspx?RootFolder=%2Fsites%2FVHASHE%2FMCMs%2FPharmacy%20%28119%29&FolderCTID=0x012000FCAA840C6EE48245B60026557A673CD9&View=%7BB191F667%2D6481%2D4328%2DB617%2DE9DD1D9AF2D7%7D https://dvagov.sharepoint.com/sites/VHASHEHCS/Local-Policy-Center/