04. Current and Future APF Room and PEC Needs.xlsx
XLSX spreadsheet 16 KB Posted
- Attached to
- NIH CC Aseptic Processing Facility (APF) Certification and Testing Program Federal contract opportunity
- Solicitation number
- HHSN-21-Q-000048
About this file
This document contains details regarding a federal solicitation for certification and testing services for the Aseptic Processing Facility at the National Institutes of Health Clinical Center. The solicitation is seeking a firm-fixed price IDIQ contract to provide cleanroom certification, HEPA filter testing and maintenance, air visualization studies, equipment calibration, and controlled temperature unit qualification program services at NIH APF facilities in Bethesda, Maryland. The base period of performance is one year with four one-year option periods. Quotes are due by April 9, 2021 and award is intended by May 1, 2021. Evaluation will be based on technical qualifications, past performance, and price, with technical/past performance more important than price. The North American Industry Classification System code is 541380 and small businesses must meet a $16.5 million annual receipts standard.
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Text version
APF - Current
| APF Certification | ||||||||||||||||
| Area | # ISO Classified Rooms | # of CNC Rooms | Total # of HEPA filters (ISO and CNC) | Total Number of HEPA equipped Passthrus | Total # of Non-viable air samples - ISO | # of PECs (LAFW/BSC/Isolator) | # of Rooms for AVS | Frequency of Room Certification (per year) | Frequency of PEC certification (per year) | |||||||
| CQV End Date or most recent room certification/HEPA testing | Satisfactory AVS performed (Yes/No) | PEC Certification | Date of next required Room Cert | Date of next Required PEC cert | Contact Person | Notes | ||||||||||
| I-IVAU | 10 | 11 | 39 | 0 | 90 | 5 | 0 | 2 | 2 | 12/11/19 | Yes | 12/11/19 | 6/30/20 | 6/30/20 | M. Ferron |
C. Hamilton
| 2J | 17 | 3 | 39 | 1 | 100 | 10 | 0 | 2 | 2 | 12/9/19 | Yes | 12/9/19 | 6/30/20 | 6/30/20 | R. Somerville |
| 3T | 14 | 3 | 15 | 0 | 98 | 15 | 0 | 0 | 2 | 12/14/19 | N/A | 12/14/19 | 6/30/20 | 6/30/20 | R. Somerville |
| 1B42 and Support Lab | 3 | 0 | 5 | 0 | 13 | 4 (2 in 1B42, 2 in Support Lab) | 0 | 2 | 2 | 12/11/19 | Yes | 12/11/20 | 6/30/20 | 6/30/20 | Rachel Beyer |
Hyunmi Halas cGMP Trailer 10B 2 1 8 1 13 1 0 2 2 2/27/20 Yes 2/26/20 8/31/20 8/31/20 Rachel Beyer Hyunmi Halas
| PET GMP and Radiopharm | 3 | 1 | 23 | 2 (1 of 2 pending install) | 9 | 3 | 3 | 1 - CNC | |
| 2 - GMP | 2 | 3 GMP HEPA units : Sept 2019 | |||||||
| 20 CNC HEPA units : Mar 2019 | Yes | 9/2019 (2 units) | |||||||
| 12/2019 (1) | 3/30/2020 (3 GMP units + 20 CNC units) | ||||||||
| 3/30/2020 (2 units) |
6/30/2020 (1 unit) Taraneh Norouzi 5 total PECs, 2 currently not in use CNC HEPA annual, GMP HEPA semi-annual
| Pharm | |||||||||||||||
| 3-1741 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 3/11/20 | N/A | 3/11/20 | TBD | 9/30/20 | M. Ferron |
| C. Hamilton | will require dP and ACH calculations for room | ||||||||||||||
| CRC TIL (3W) and Support Lab | 2 | 0 | 6 + 1 FFU | 0 | 29 | 5 - CPF | |||||||||
| 2-Support Lab | 2 | 1 | 1 - Support Lab | ||||||||||||
| 2 - CPF | 6/1/19 | No | 12/1/19 | 6/30/20 | 6/30/20 | Rachel Beyer | |||||||||
| Hyunmi Halas | Support Lab Annual testing |
CPF semi-annual DTM - Blood Bank (ad hoc only) 0 0 0 0 0 3 0 0 2 N/A N/A 9/1/19 N/A 4/1/20 William Ward
Totals 51 20 136 4 352 49 5
APF - Upcoming
| APF Certification | ||||||||||||
| Area | # ISO Classified Rooms | # of CNC Rooms | Total # of HEPA filters (ISO and CNC) | Total Number of HEPA equipped Passthrus | Total # of Non-viable air samples - ISO | # of PECs (LAFW/BSC/Isolator) | # of Rooms for AVS | Frequency of Room Certification (per year) | Frequency of PEC certification (per year) | |||
| Current CQV End Date | Contact Person | Notes | ||||||||||
| cGMP Trailer 10B | 2 | 1 | 8 | 1 | 10 | 3 | 2 | 2 | 2 | 2/27/20 | Rachel Beyer |
Hyunmi Halas
| Pharm | |||||||||||
| 3-1741 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 4/1/20 | M. Ferron |
C. Hamilton
| E-IVAU | 6 | 3 | 21 | 4 | 26 | 4 | 6 | 2 | 2 | 5/9/20 | M. Ferron | |
| C. Hamilton | Haz. Storage will require annual dP and ACH calculations | |||||||||||
| TIL (modular) | 10 | 4 | 56 | 0 | 71 | 10 | 10 | 2 | 2 | 9/24/20 | Rachel Beyer |
Hyunmi Halas
| Sterility Lab | 5 | 0 | 16 | 4 | 23 | 5 | 5 | 2 | 2 | 12/1/20 | Anna Lau |
| Terrace Modules | 15 | 3 | 55 | 10 | 64 | 4 | 15 | 2 | 2 | 12/2/20 | R. Somerville |
| P-IVAU | 29 | 5 | 58 | 31 | 162 | 12 | 29 | 2 | 2 | 12/1/21 | M. Ferron |
C. Hamilton
| 12E | 24 | 10 | 126 | 8 | 166 | 16 | 24 | 2 | 2 | 12/13/21 | R. Somerville | |
| Radio pharmacy | 6 | 3 | 15 | 3 | 32 | 3 | 6 | 2 | 2 | 2/1/22 | Ken Chang | estimated # of HEPA filter |
| 29B Pilot Plant | 12/1/23 | Christpopher Hanson | estimated # of HEPA flters |
Totals 95 28 347 60 544 54 95
File details come from the government source that posted it. Updated .