S05 Technical Questions and Answers.pdf
PDF 64 KB Posted
- Attached to
- H365--Pharmacy Clean Room Hood Testing & Cert - STC (VA-26-00011944) (FIRST Testing MUST be conducted on February 2nd and 3rd - NO EXCEPTIONS) Federal contract opportunity
- Solicitation number
- 36C26326Q0103
About this file
This document contains a set of questions and answers related to a VA (Veterans Affairs) contract opportunity, focusing on technical and personnel requirements for a specialized testing service. The Q&A addresses key details including incubation method (dual plate), contract line item (CLIN) specifics for sample analysis and plate provision, and personnel qualifications for performing USP <797> and <800> standard testing. Specifically, the document clarifies that the contract awardee is responsible for providing media plates, technicians must have 2 years of experience with USP standards in ISO 5 and 7 environments, and that the person reviewing test certifications does not need to be the on-site technician, though on-site personnel must meet specific qualification criteria.
View the file
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| 36C26326Q0103 0001_1.docx | DOCX document | |
| Wage Determination 2015-4953.pdf | ||
| S02 36C26326Q0103.pdf | ||
| 36C26326Q0103_1.docx | DOCX document |
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Text version
1. Does the VA request dual or single plate incubation? Dual plate incubation
2. CLIN 0006: does this also include analysis of the surface and air samples? Yes. See item 2 of the SOW, page 4.
3. CLIN 0015: should cost of plates be included in this line item? Plates to be provided by company awarded the contract. All costs associated with this test should be included in this CLIN.
4. Clarify who is responsible for providing media plates for gloved fingertip and media fill test kits. Company awarded the contract.
5. For Section 2.i., does the contractor’s testing personnel need to have 2 years of experience performing USP <797> and <800> work or just experience performing the noted SOW in any setting (i.e. GMP or med device)? 2 years of experience and training on fundamental practices and precautions within current USP <797> and <800> standards and operations within ISO 5 and 7 environments.
6. For Section 2.ii., can the person reviewing and signing the testing/certifications be someone not onsite/local or does this have to be one of the technicians performing the work noted in SOW? The person reviewing and signing does not need to be the person on site performing the work – however, the person on-site completing the work should meet 2.iii and 2.iv.
File details come from the government source that posted it. Updated .