The following questions must be answered and included in the response to this Sources Sought Notice.   Only the submitted Capabilities Statements that include answers to the following questions will be included in the evaluation process.

Clean rooms sterility and cleaning protocols are regulated by the Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) 797. Please provide information regarding previous experience with sterilizing Clean Rooms.  

1) Provide Past Performance information (PPI) from at least 3 but not more than five facilities. PPI shall include the names and types of facilities, address of the facility, contact at the facility, and outcome quality as measured by the facility or third party.

2) Provide a list of cleaning agents you have used in the clean room facilities and methods of disposal.

3) Provide a list of Personal Protective Equipment (PPE) used by personnel during cleaning activities and the protocol established for using the PPE.

4) Provide protocols for coupon testing and responses to alert limits from environmental monitoring.

5) Provide your employee training protocols and proceedures and methods of your developed system for employee retention.

6) Please provide any documentation on order of cleaning and entry into ISO8 and ISO7 classified spaces.

NIH must receive written capability statements no later than January 20 at 9:00 a.m. Eastern Time. E-mail the written capability statement directly to Lisa Schaupp, the Contract Specialist, at the e-mail address [email protected].

Respondents will NOT be notified as to the results of the Government's market research.

Please acknowledge receipt of both Amendment 1 and Amendment 2 adding question and response requirements to the Sources Sought Notice.

Thank you,

Lisa Schaupp

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