S06 - 36C25625Q1498 Pharmacy Testing Questions 002.pdf

36C25625Q1498 – Pharmacy Testing Certification of Sterile Compounding Areas Questions and Answers

1. Can you provide a drawing of the pharmacy? This will help us with accurate numbers for the submittal. If not a total number of HEPA filters to be tested and the square footage of each room. Should be able to find on past certifiers reports.

I’ve attached our newest sampling diagram to this email for our cleanroom suites.

We also have an SCA that contains an CAI. We sample inside the pass through and the main chamber. We also have a C-SCA that contains an CACI. We sample inside the pass through and the main chamber of that isolator as well. We have 4 compounding hoods/isolators total, each requiring a HEPA filter. We also have 6 HEPA filters in the ceilings of our cleanroom suites. We have one pass through in each of our buffer rooms for the cleanroom suites that have a HEPA filter that we do not test.

2. For HD sampling it asks for 7 testing locations. Do you know how many drugs and which ones will be testing for?

For previous sampling, we’ve tested for doxorubicin, paclitaxel, 5-fluorouracil, cyclophosphamide, ifosfamide, methotrexate, and other water soluble platinum containing drugs. A resource is here that is the exact test and lab that is used à https://www.eurofinsus.com/environment-testing/built-environment/subservices/usp-environmental-monitoring/usp800/

3. It states that the facility will be conducting their own monthly sampling, all materials and incubation to be provided by the vendor. That is not a problem. My question is it also states in section E.1 that these will be taken quarterly as well? CETA standard is monthly, thinking this might be an oversite.

Myself, and our IV technician, are certified to collect monthly surface samples during months we do not have a visit from Winergy. Every quarter, 4 months a year, Winergy performs a site visit to recertify certain compounding hoods and to collect viable sampling. Viable sampling includes surface and air sampling. No one at OBVAMC is certified to collect air samples nor do we have the equipment necessary to do so. We have Winergy collect viable samples during quarterly visits to meet our monthly surface sample USP 797 requirement and to collect air samples which are a necessary USP 797 requirement to recertify an ISO room and/or compounding hood. Having a 3rd party CETA certified technician collect these samples is the most preferred method of collection.

4. Three areas have been identified as Cleanroom Suites (E95K, E95H & E95L).

a. Do the room designations relate to buffer (mixing rooms) only?

1E95L = Chemo (hazardous) buffer room. 1E95K = anteroom. 1E95H= Nonhazardous buffer room.

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b. Do the room designations relate to C-SCAs or are C-SCAs separate?

C-SCA is located in room 1E300. C-SCA is where our CACI is located.

c. How many rooms (buffer and ante rooms) by ISO-7 and ISO-8 designation are associated with each location listed?

The cleanroom suites consist of 3 ISO 7 rooms. The anteroom is ISO 7.

The nonhazardous buffer room is ISO 7. The chemo (hazardous) buffer room is ISO 7.

5. How many HEPA filters are operational in each of the Cleanroom Suites or in their associated rooms?

The cleanroom suites have 6 total ceiling HEPA filters (2 in each room). We do not test the two HEPA filters in the pass through for leaks.

This does not include the HEPAs in the PECs.

6. What are the sizes of the HEPA filters (2x2, 2x4,4x4)?

Ceiling – 2X4

7. How many extra (non-scheduled) visits for re-testing of failed biological/fungal samples were recorded in the past year or semi-annual period?

We have scheduled 3 retests since March 1st 2025 for failed and/or recollecting samples. I would recommend planning for a re-testing visit after each certification visit.

8. Is it anticipated that microbiological sampling will be accomplished through a dual-plate or single-plate method?

Single-plate. Irradiated TSA contact plates preferred.

9. Is NSF accreditation required for certification of LAFW, BSC, CACI & CAI equipment?

It is preferred that on-site certification individuals have received NSF accreditation for the filed certification of Class II Biosafety Cabinets and are accredited through CNBT as a registered certification professional in the sterile compounding facility.

10. When HEPA filter replacement is required, is the supplier responsible for procurement of the filter?

No

11. Is the HEPA filter replacement billed as a labor rate?

Yes

12. Is re-certification of the new HEPA filter allowed as an additional certification outside the normal schedule?

Yes, but it would be preferable to have new HEPA filters installed during normal recertification.

13. Please provide the number of Primary Engineering Controls (PECs) in the facility by classification.

- Number of LAFW? 1

- Number and size of BSC? 1

14. What is the number and type of cabinets (Type II, B2, Type II, B3)?

- Number of CACI? 1 Hard Duct

- Number of CAI? 1 Non-vented

- Number of C-SCA? 1

15. Please provide the Manufacturer and Model Number of each PEC.

LAFW – Baker EdgeGARD HF. Model – EG6252

BSC – Baker SterilGARD e3 – Class II A2. Model – SG604

CAI – Baker SterilSHIELD – Non-vented. Model – SS500

CACI- Baker ChemoSHIELD- Hard Duct. Model- CS500