New PWS External Vendor Cleanroom Certification and Emergency Response Work.doc

Performance Work Statement External CETA Professional Every 6-Month Cleanroom Certification & Emergency Response Work General Overview In order maintain our status as a 503A pharmacy and to compound intravenous medication for patients we need a functioning cleanroom. In order to function from a regulatory and safety standpoint we must have a CETA certification regarding everything listed below from a registered CETA-professional (per VHA Directive 1108.12). This is highly precise and technical work that forms the foundation of our USP and Joint Commission compliance.

A CETA professional shall have a physical location in New England (~=<200 miles from Togus, ME) and shall provide timely emergency response services as required.

A CETA professional that would offer to hire a local non-CETA certified subcontractor is not allowed under VA directive 1108.12. Requirement restricts to a CETA professional at VA Maine and must maintain VISN compliance. The Vendor must be able to perform within Scope.

ISO-designated cleanrooms are dynamic environments that will require both scheduled and non-scheduled maintenance which results in the need for prompt local CETA experienced remediation and on-site CETA counseling service. As an example, VA Maine has a history of temperature and humidity excursions, damaged HEPA filters and repeat viable testing needs that require immediate attention. A 24 hour response time is mandatory for all instances. This is a base plus 3 option year contract.

1.0 Introduction

The VA Maine HCS Pharmacy Service cleanroom is required per United States Pharmacopeia (USP) chapter <797>, federal and state regulations to relent to inspection on a semiannual basis to verify standards within a cleanroom are followed when preparing compounded sterile preparations for human use. Before a sterile compounding area is used and every 6-months it must be certified/recertified to meet design and air quality specifications on a continuous basis. Emergency service is often required in these spaces to address variances in parameters and physical state.

2.0 Background

Sterile compounding facilities must be designed, outfitted, and maintained properly to minimize the risk of contamination of compounded sterile preparations (CSPs). The required air quality must be achieved and maintained through primary engineering controls (PECs) and secondary engineering controls (SECs). The design of the facility should consider the number of personnel, their movements, equipment, supplies and components to maintain/facilitate the maintenance of air quality. The number of operations being performed, the equipment (e.g., PECs, carts, computers), the personnel in the compounding area (and in adjacent areas), and the complexity of the compounding procedures are critical considerations for maintaining control of environmental conditions in the facility.

USP <797> requires Controlled Environment Testing Association (CETA) and Controlled Applications Guides (CAGs) be used as a basis of certification standards. CETA-CAGs define certification procedures to assess the secondary engineering controls and primary engineering controls are performing and operating as designed to maintain a sterile environment for the preparation of compounded sterile preparations.

Per Directive 1108.12, VA is adopting CETA-CAGs as the mandatory standard; no “equivalent” standards may be used: ISO 14644-1:2015, IEST-RP-CC006.2, CETA CAG-003-2006-13, NSF ANSI 49-2012, and NEBB Procedural Standard for Certified Testing of Cleanrooms.

3.0 Scope of Work

Vendor to perform tests in accordance with ISO 14644-1:2015, IEST-RP-CC006.2, CETA CAG-003-2006-13, NSF ANSI 49-2012, and NEBB Procedural Standard for Certified Testing of Cleanrooms.

Deliverables:

Vendor shall report to VA Maine HCS on a semiannual basis to complete this work on pre-agreed upon dates and times.

Vendor shall respond to VA Maine Pharmacy Service need for emergency counsel and or service on an ad hoc basis.

The current space is ~570sqft and comprised of 4 rooms, sketch below. Equipment needed to complete the work should be determined by CETA professional in accordance with certification requirements. Similarly, the environmental sampling plan should also be determined by the CETA professional in collaboration with the pharmacy leadership. All requested services are subject to change as we anticipate modifications to our cleanroom space. See layout below.

In-Place Filter Leak Scan of HEPA Filter Bank:

Challenge material will be introduced into air handler and system scanned from within cleanroom for detection

ISO 14644 Testing:

Airflow Volumes and Calculation of Air Changes Per Hour Utilizing Electronic Manometer and Capture Hood Airborne Particle Counts ISO Classification at particle sizes ≥ 0.5 micron utilizing discrete light scattering particle counter and 1 CFM 1-minute samples. Room Pressurization performance of differential pressure testing utilizing electronic multimeter.

Certification of existing Biological Safety Cabinets and Containment Ventilated Enclosures (BSCs / CVEs):

Testing Performed in Accordance with NSF ANSI 49-2012, and CETA CAG-003-2006-13

Certification of existing Compounding Aseptic Isolator (CAI):

Testing Performed in Accordance with Manufacturer’s Specifications CAG-002-2006

Videotaping of Dynamic Smoke Studies:

BSCs, CAI and provision of a DVD with videos

Viable Environmental Monitoring- Single Media:

Includes volumetric air samples and surface samples

Same-Day Notification of Abnormal Findings

Same-Day Notification of Results Prior to Final Report if required

24 Hour Completion of Final Report After Completion of Lab Processing

Same-Day Overall Preliminary Report

Final Report Transmission Within 48 Hours Mail Delivery of Physical Hard Copy Reports