QUESTIONS AND ANSWERS.pdf
PDF 95 KB Posted
- Attached to
- H266--Pharmaceutical Compounding Room/Hood Testing - VANCHCS Federal contract opportunity
- Solicitation number
- 36C26124Q0390
About this file
This document contains Questions and Answers related to a federal contract opportunity for pharmaceutical compounding room and hood testing services for the Veterans Integrated Service Network 21 (VISN 21) of the Department of Veterans Affairs Veterans Health Administration.
The key details include:
- Dimensions and quantity of HEPA filters for various compounding rooms and suites across multiple VA facilities
- Gowning procedures for personnel working in the clean rooms
- Scope of work, which includes semi-annual certification of engineering controls, viable air and surface sampling as needed, and HEPA filter replacements
- Required ISO classification for each controlled environment
- Biannual certification schedule, with additional testing as needed for events like filter changes
- Sampling plans for viable air and surface monitoring
- Inventory of equipment requiring calibration, including manufacturer, model, and serial number details
- Standard calibration requirements per applicable CETA guidelines
The related federal contract opportunity is for Solicitation Number 36C26124Q0390, titled "H266--Pharmaceutical Compounding Room/Hood Testing - VANCHCS", issued by the Department of Veterans Affairs Veterans Health Administration VISN 21.
View the file
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Gowning and Garbing procedure VANCHCS.pdf | ||
| VANCHCS Viable Sample Maps.pdf | ||
| 36C26124Q0390 0003_1.docx | DOCX document | |
| 36C26124Q0390 0002_1.docx | DOCX document | |
| 36C26124Q0390 0001_1.docx | DOCX document | |
| Past Performance Survey.docx | DOCX document | |
| 2015-5631_Rev.20_SACRAMENTO_12_26_2023.pdf | ||
| 2015-5653_Rev.19_SAN JOAQUIN_12_26_2023.pdf | ||
| 2015-5623_Rev.22_ALAMEDA_CONTRA COSTA_12_26_2023.pdf | ||
| RFQ 36C26124Q0390 - Pharmacy Hood Testing.pdf | ||
| 36C26124Q0390_1.docx | DOCX document |
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Text version
QUESTIONS AND ANSWERS
1. Reflective Ceiling Plan of your clean room. Ceiling plans will be provided (not pertinent for contract)
a. Dimensions of Rooms:
Answer: Dimensions of room will be provided (will require input from Engineering department)
b. Quantity of HEPA filters in each room:
Answer: Number of HEPA filters:
1. Martinez Oncology IV Suite: 5
2. Martinez SCA: 2
3. Mather Compounding Trailer: 5
4. Mather Inpatient SCA: 2
5. Mather Inpatient IV Suite: 4
6. Mather Oncology C-SCA: 5
7. Stockton IV Suite: 8 + 3 (pass through)
2. Gowning Procedure (if applicable)
Answer: Please see attached. Will potentially require additional Coveralls to be worn under gown for outside personnel.
3. Scope of Work for the Cleanroom
Answer: The general scope of work is semi-annual certification of all engineering controls and collection of viable samples (viable air & surface samples) on a “as needed” basis. Required repairs on
PECs and changing of HEPA filters if required.
4. Room Acceptance Criteria (ISO Class)
Answer: ISO Class for each SEC is provided on the attached sampling plans
5. Cycle of Certification (How often do you want the Testing done- Yearly, Biannual, Quarterly)
Answer: Testing for all IV rooms is performed biannually and “as needed” for initial certifications, re-testing, and/or after remodeling or other events (e.g., changing of HEPA filters)
6. If Viable Sampling is required – Sampling Plan
Answer: See attached Sampling Maps. Viable Sampling will only be required on an “as needed” basis as contingency and /or during semi-annual re-certification. Routine monthly surface sample will be collected in-house.
7. Equipment Inventory of units needing Calibration. Make sure the list provides the following details of the unit:
a. MFR
b. Model
c. Serial Number
Answer: See attached excel sheet for PEC info – Stockton PEC equipment is TBD
8. Are there any Calibration Requirements/Special Instruction?
Answer: No, standard according to applicable CETA CAGs
File details come from the government source that posted it. Updated .