Attachment 2 - Questions and Answers.pdf

Questions and Answers - 36C25926Q0056

Question 1: I am seeking clarification as to whether line 005 refers to additional hoods not listed in the SOW? If so, what is the area classification for the Pharmacy B2 (i.e. HD Buffer, HD

SCA).

Answer 1: There are a quantity of two (2) of the Nuaire NU-430-400 hoods. One located in the Pharmacy , and the other located in the Lab. There is only one (1) Baker Edgeguard EG-6320 hood Located in the Pharmacy.

Question 2: Number of rooms in the pharmacy?

Answer 2: The pharmacy suite is made up of the Ante room (rm 160), the non-hazardous buffer room (rm 160A), and the hazardous buffer room (rm 160B)

Question 3: Number of HEPAs in the pharmacy?

Answer 3: There are 4 HEPA filters in the pharmacy air handling system. Then there are HEPA filters in the specified hoods as well.

Question 4: Square footage of the rooms?

Answer 4: Hazardous Buffer Room is approximately 52 sqft.

Non-Hazardous Buffer Room is approximately 62 sqft

Ante Room is approximately 81 sqft

Question 5: Is there a viable sampling plan available?

Answer 5: Certifier to collect air and surface samples as part of the CETA certification of class 7 rooms every 6 months

Question 6: The total number of HEPA units at the facility?

Answer 6: There are 4 HEPA filters in the pharmacy air handling system. Then there are HEPA

Question 7: The required number of surface and air microbial samples?

Answer 7: Will attach the SOP (SOP 119-15) for the Pharmacy IV Room Air and Surface Monitoring.

Question 8: Could you please confirm how many HEPA filters are included in this scope?

Answer 8: There are 4 HEPA filters in the pharmacy air handling system. Then there are HEPA

Question 9: Can you provide the approximate room sizes or square footage for the compounding, buffer, and ante rooms to assist with particle count and airflow calculations?

Answer 9: Hazardous Buffer Room is approximately 52 sqft.

Non-Hazardous Buffer Room is approximately 62 sqft

Ante Room is approximately 81 sqft

Question 10: Are there designated locations for microbial sampling, or should the contractor determine those based on CETA standards?

Answer 10: Will attach the SOP (SOP 119-15) for the Pharmacy IV Room Air and Surface Monitoring.

Question 11: Are there any Layout drawings of pictures of the Pharmacy Compounding Area?

Answer 11: Floor plan

Pharmacy Surface sampling sheet:

Question 12: Item #0005 references a Class II, Type B2 biosafety cabinet located in Room 160- O within the Pharmacy. Can you please confirm whether this unit is part of the required certification scope?

Answer 12: Yes, it is part of the certification scope.

Question 13: The SOW mentions bacterial and fungal sampling within the “air handler.” Could you confirm whether this testing is to be performed within the HVAC system or if this statement refers only to cleanroom areas?

Answer 13: The SOW has been clarified; “air handler” is associated with the sentence that follows, “Provide controls needed. Adjusted HVAC system to provide the code required Air Changes Per Hour (ACPH) in each space.”

Question 14: Could you confirm the intended scope of Item #0006 “Recertifications as needed”?

Should this cover post-repair/maintenance retesting or be included for potential failed certifications?

Answer 14: The line-item is intended for both potential indications.