Preventative maintenance and calibration services for general laboratory equipment for FDA Division of Biological Standards and Quality Control (DBSQC), Office of Compliance and Biologics Quality (OCBQ), Center for Biologics Evaluation and Research (CBER) 75F40125Q130197

This Solicitation is for the purchase of onsite preventative maintenance and ISO 17025 accredited calibration services for general equipment such as refrigerators, freezers, refrigerator/freezer combo units, incubators, CO2 incubators, ovens, water baths, centrifuges, PCR Workstations, digital thermometers, hygrometers, and chart recorders and hygrometers for DBSQC. DBSQC serves as a Standards Preparation and Testing laboratory for CBER. DBSQC is also an ISO 17025 accredited testing laboratory of CBER. The samples deposited by Sponsors (Industry) for licensing and lot release approvals are tested in DBSQC, OCBQ, CBER. See attached DBSQC Equipment list.

8/21/2025 Question. Who would be responsible to pay and order PM kits (Hepa Filters, Filters, etc.) if a unit is required to replace during the PM? Response: After preventative maintenance / calibration the contractor shall make any recommendations to change consumable such as air filters etc. CBER may purchase this under a separate contract and either install or have the Contractor install the Government provided Equipment on the next scheduled PM visit. This Solicitation is for the purchase of onsite preventative maintenance and ISO 17025 accredited calibration services for general equipment such as refrigerators, freezers, refrigerator/freezer combo units, incubators, CO2 incubators, ovens, water baths, centrifuges, PCR Workstations, digital thermometers, hygrometers, and chart recorders and hygrometers for DBSQC. DBSQC serves as a Standards Preparation and Testing laboratory for CBER. DBSQC is also an ISO 17025 accredited testing laboratory of CBER. The samples deposited by Sponsors (Industry) for licensing and lot release approvals are tested in DBSQC, OCBQ, CBER. See attached DBSQC Equipment list.

8/26/2025: Question: Is the below statement saying that there will only be 5 days available throughout the year to complete these services, or will the list be broken into 5 separate service times throughout the year and we will have more than one day to service what is requested during that time? The due dates for the preventative maintenance, calibration, certification of equipment of DBSQC may fall on different days all through the year. The above activities for all the equipment in the contract will be scheduled for no more than five (5) visits per year. Response: The statement does not indicate that only 5 days will be available throughout the year to complete these services. Rather, It says that the list may be broken into 5 or less separate on-site service visits throughout the year and each visit the service provider can have more than one day to complete. The service provider shall coordinate with the TPOC on the service days and provide the estimated duration of such for each service visit. 8/21/2025 Question. Who would be responsible to pay and order PM kits (Hepa Filters, Filters, etc.) if a unit is required to replace during the PM? Response: After preventative maintenance / calibration the contractor shall make any recommendations to change consumable such as air filters etc. CBER may purchase this under a separate contract and either install or have the Contractor install the Government provided Equipment on the next scheduled PM visit. This Solicitation is for the purchase of onsite preventative maintenance and ISO 17025 accredited calibration services for general equipment such as refrigerators, freezers, refrigerator/freezer combo units, incubators, CO2 incubators, ovens, water baths, centrifuges, PCR Workstations, digital thermometers, hygrometers, and chart recorders and hygrometers for DBSQC. DBSQC serves as a Standards Preparation and Testing laboratory for CBER. DBSQC is also an ISO 17025 accredited testing laboratory of CBER. The samples deposited by Sponsors (Industry) for licensing and lot release approvals are tested in DBSQC, OCBQ, CBER. See attached DBSQC Equipment list.

8/28/2025: Question: With regards to the solicitation, can you please provide the manufacturer and model information for the equipment?” Response: The solicitation question date has passed. We do not have a list of the manufacturer or model number for the equipment. The CBER customer has indicated that the listed equipment is standard equipment in any typical laboratory in the USA. Most of the refrigerators, freezers, incubators, etc. are made by Thermo Fisher Scientific. 8/26/2025: Question: Is the below statement saying that there will only be 5 days available throughout the year to complete these services, or will the list be broken into 5 separate service times throughout the year and we will have more than one day to service what is requested during that time? The due dates for the preventative maintenance, calibration, certification of equipment of DBSQC may fall on different days all through the year. The above activities for all the equipment in the contract will be scheduled for no more than five (5) visits per year. Response: The statement does not indicate that only 5 days will be available throughout the year to complete these services. Rather, It says that the list may be broken into 5 or less separate on-site service visits throughout the year and each visit the service provider can have more than one day to complete. The service provider shall coordinate with the TPOC on the service days and provide the estimated duration of such for each service visit. 8/21/2025 Question. Who would be responsible to pay and order PM kits (Hepa Filters, Filters, etc.) if a unit is required to replace during the PM?” Response: After preventative maintenance / calibration the contractor shall make any recommendations to change consumable such as air filters etc. CBER may purchase this under a separate contract and either install or have the Contractor install the Government provided Equipment on the next scheduled PM visit. This Solicitation is for the purchase of onsite preventative maintenance and ISO 17025 accredited calibration services for general equipment such as refrigerators, freezers, refrigerator/freezer combo units, incubators, CO2 incubators, ovens, water baths, centrifuges, PCR Workstations, digital thermometers, hygrometers, and chart recorders and hygrometers for DBSQC. DBSQC serves as a Standards Preparation and Testing laboratory for CBER. DBSQC is also an ISO 17025 accredited testing laboratory of CBER. The samples deposited by Sponsors (Industry) for licensing and lot release approvals are tested in DBSQC, OCBQ, CBER. See attached DBSQC Equipment list.