Q and A 25 June 2024 Cleanroom_Signed.pdf

DEPARTMENT OF THE AIR FORCE

AIR FORCE LIFE CYCLE MANAGEMENT CENTER (AFLCMC)

WRIGHT-PATTERSON AIR FORCE BASE OHIO

25 June 2024

FROM: AFLCMC/PZIBA

1940 Allbrook Drive, Room 109 Wright-Patterson AFB, OH 45433

SUBJECT: Response to Inquiries regarding Hazardous and Non-hazardous Clean Room Testing

FA8601-24-Q-0111

1. QUESTION: In paragraph 3.3. Hazardous Cleanroom Certification Per Room and 3.6. Non-Hazardous Cleanroom Certification Per Room, both have an 'Additional Testing Not Included (Unless specified on this quote):' line. Are the testing methods following this callout required for this project?

ANSWER: Yes, they we are required to retest when one or more tests fail, but in the event that all test pass there will be no requirement to retest therefore it is difficult to name what is required when that is an unknown until initial biannual test results are received.

2. QUESTION: There is still confusion as the PWS paragraphs 3.3.1.5 and 3.6.7 both say Additional Testing Not Included (Unless specified on this quote). Our pricing would not include any test below this statement. Does this align with the Governments interpretation of the PWS i.e. any test cited after these paragraphs in the list do not have to be included in the pricing?

ANSWER: Paragraphs 3.3.1.5 and 3.6.7 have been removed from the updated

PWS.

3. QUESTION: A compliant USP 797 requires the following:

VIABLE SAMPLING IN PASS THROUGHS OR HOODS,

HOOD CERTIFICATIONS

HEPA CHALLENGES

The items below were missing from the solicitation, scope of work. Can you kindly clarify? The design may incorporate a dedicated HD storage room with an anteroom, which is the standard for USP 797.

ANSWER: Yes, all USP 797 assessments need to be accomplished if those identified are not in the package for solicitation then it is an oversight.

4. QUESTION: We would like to kindly request some additional details that is needed to provide the services that the government is requesting and to be fully compliant with 797 USP and 800 USP standards, kindly note that this is not available in the solicitation and scope of work. Specifically, details on:

Number of HEPA and where there are test ports.

Type of hoods and quantity of each type.

Number of passthroughs between rooms.

Some definitions to fully clarify:

HEPA Filters: Both standards require HEPA-filtered air to minimize contamination in the clean room. HEPA filters trap tiny particles that could otherwise pollute the air and medications. There's no set number required; it depends on the size of the clean room. Without having an exact count, we're unable to offer a precise quote.

Test Ports: These are access points for taking air samples to monitor the cleanliness of the air inside the clean room. The exact location of the test ports depends on the specific layout of the clean room, but they are typically placed in strategic areas to get a good overall picture of air quality. Scope of work did not mention anything regarding this.

Hoods: USP 800 requires a specific type of hood called a Biological Safety Cabinet (BSC) for compounding hazardous drugs. This hood protects personnel from exposure to the drugs. USP 797 doesn't require a BSC but may recommend a fume hood for certain volatile chemicals. The number of hoods depends on the workload and type of medications being compounded. We cannot guess something like this.

Passthroughs: These are small compartments that allow materials to be transferred between rooms without someone physically entering the clean room. This helps to minimize contamination. The number of passthroughs depends on the layout of the clean room facility and how materials typically flow between different areas. We also need this to provide the government with accurate pricing. “

ANSWER:

- Number of HEPA and where there are test ports.

3 HEPA Hazardous Mixing, 1 HEPA Ante Hazardous, 1 HEPA Non-Hazardous, 1 HEPA Non-Hazardous Ante room.

Test ports are located before each HEPA.

- Type of hoods and quantity of each type.

Type of hoods and quantity of each type. HD cleanroom has: 2x Baker BSC (ISO

5) hoods. Non-HD cleanroom: 1x Panasonic BSC (ISO 5) hood

- Number of passthroughs between rooms.

HD cleanroom has: 1x pass thru (ISO 7) Non-HD cleanroom has: no pass thru.

5. QUESTION: There are currently no certifications required for the technician providing the testing. The industry standard is to have the technician have the NSF-49 certification (if the facility has biological safety cabinets that need testing) and the CETA Registered Cleanroom Certification for any work performed in the pharmacy. Does the gov’t wish to define this as a requirement in the PWS or is it okay to have an uncertified technician perform all of this work?

- The only items listed to be tested were a hazardous cleanroom (section 3.3) and a non-hazardous cleanroom (section 3.6). There is no mention of an ante room, a hazardous drug storage room or any other room. If the government wishes to have additional rooms tested, please provide the following information:

a. Room number

b. Room name

c. Number of room pass throughs (if any).

d. Number of ceiling-mounted supply HEPA filters (if any).

e. Number of viable surface samples to be collected within the room (including any pass throughs).

f. Number of viable air samples to be collected within the room.

- There are no primary engineering controls (PECs) listed in the PWS. Typically, when a pharmacy has the rooms certified, the PECs are certified as well. If the gov’t has pharmacy equipment to be tested, please provide the following information:

a. Room number

b. Make and Model

c. Serial Number (not required, but provide it if available)

d. Does the pharmacy wish to have video recorded smoke testing performed in the

PEC? If so, list this as a requirement. USP 797 does not directly require this, but CETA CAG testing protocols require this and most government medical facilities are having these videos collected.

- If ceiling HEPA filters are to be leak tested, test aerosol must be injected upstream of the HEPA filter. This is typically done by connecting to an upstream aerosol test port (usually mounted in the ceiling). Please verify that these critical ports are installed (must be a minimum of 1/2” diameter ports). If they are not available, there is additional labor that each contractor must include to perform the HEPA leak testing.

- Sections 3.3.1.10 and 3.6.12 request a room recovery test. This is neither a standard test nor is it a test mentioned within USP 797 or 800. Furthermore, this test is not described in the PWS and is only listed by its name. It is assumed that this test is not required by DoD or DHA as no other military hospitals request this test. It is assumed that this is a typo. If this test is actually a requirement, please include a description of the test the pharmacy is requesting.

- USP now requires monthly surface sampling, but this was not mentioned in the PWS. Please clarify that the government does not want the contractor to include monthly surface sampling. If monthly surface sampling is needed, please identify the total number of samples requested each month.

ANSWER: Please see responses below in red.

- There are currently no certifications required for the technician providing the testing. The industry standard is to have the technician have the NSF-49 certification (if the facility has biological safety cabinets that need testing) and the CETA Registered Cleanroom Certification for any work performed in the pharmacy. Does the gov’t wish to define this as a requirement in the PWS or is it okay to have an uncertified technician perform all of this work?

The testing needs to be validated and there needs to be some kind of assurance that the technician has knowledge of how testing should be conducted, if not certified then some other kind of training/knowledge presentation.

The only items listed to be tested were a hazardous cleanroom (section 3.3) and a non-hazardous cleanroom (section 3.6). There is no mention of an ante room, a hazardous drug storage room or any other room. If the government wishes to have additional rooms tested, please provide the following information:

All information is in the attached except room numbers below.

a. Room number – HAZ anteroom (1U25) / HAZ buffer room (1U26) / nonHAZ anteroom (1U27) / nonHAZ buffer room (1U28)

b. Room name

c. Number of room pass throughs (if any).

d. Number of ceiling-mounted supply HEPA filters (if any).

e. Number of viable surface samples to be collected within the room (including any pass throughs).

f. Number of viable air samples to be collected within the room.

- There are no primary engineering controls (PECs) listed in the PWS. Typically, when a pharmacy has the rooms certified, the PECs are certified as well. If the gov’t has pharmacy equipment to be tested, please provide the following information:

MERC is executing on equipment contract for the PECs ideally, we contract the same company so all testing can be accomplished at the same time.

a. Room number

b. Make and Model

c. Serial Number (not required, but provide it if available)

d. Does the pharmacy wish to have video recorded smoke testing performed in the

PEC? If so, list this as a requirement. USP 797 does not directly require this, but CETA CAG testing protocols require this, and most government medical facilities are having these videos collected.

- If ceiling HEPA filters are to be leak tested, test aerosol must be injected upstream of the HEPA filter. This is typically done by connecting to an upstream aerosol test port (usually mounted in the ceiling). Please verify that these critical ports are installed (must be a minimum of 1/2” diameter ports). If they are not available, there is additional labor that each contractor must include to perform the HEPA leak testing.

- Review updated PWS.

- Sections 3.3.1.10 and 3.6.12 request a room recovery test. This is neither a standard test nor is it a test mentioned within USP 797 or

800. Furthermore, this test is not described in the PWS and is only listed by its name. It is assumed that this test is not required by DoD or DHA as no other military hospitals request this test. It is assumed that this is a typo. If this test is actually a requirement, please include a description of the test the pharmacy is requesting.

- Room recovery – any testing needed to bring the room back to confidence, a failed semiannual test or required testing after significate down time, this exact verbiage may not be in 797 but the requirement to retest failed items and test out of cycle following significant room downtime are requirements that need to be available to execute when needed.

- USP now requires monthly surface sampling, but this was not mentioned in the PWS. Please clarify that the government does not want the contractor to include monthly surface sampling. If monthly surface sampling is needed, please identify the total number of samples requested each month. Local pharmacy teaming with local lab accomplishes these.

6. QUESTION: Are mechanical drawings, reflected ceiling, and floor plans of the cleanrooms with room dimensions in ft2 (please include ceiling ht.)?

ANSWER:

7. QUESTION: Can you provide a copy of the most recent certification report?

(Feel free to white out the providers contact info. It will help us understand the scope of the project more quickly)

ANSWER: Review provided attachments.

8. QUESTION: If drawings are unavailable, please provide the following information:

HEPA filter quantities

Room size(s) in square footage/ ceiling height

How many doorways

ISO classification

ANSWER: Review provided attachments.

CANDICE L. SNOW

Contracting Officer

AFLCMC/PZIBA