Trocar Sterilization

• Country: Uganda
• Summary: Trocar Sterilization
• UGT Ref No: 62779263
• Deadline: 04 Feb 2022
• Financier: Other Funding Agencies
• Purchaser Ownership: -
• Tender Value: Refer Document
• Notice Type: Tender
• Document Ref. No.:
• Purchaser's Detail:

Purchaser : FAMILY HEALTH INTERNATIONAL (FHI 360)
Attn: Dishanti Shah
Email :dshah@fhi360.org, fhipartners@fhi360.org

• Description:
• Request for proposals are invited for Trocar Sterilization. RFP posted: 2/1/2022 Proposal submission deadline: 2/4/2022 Anticipated Award Start Date: 2/21/2022. SCOPE OF WORK1 The PDI team is seeking a laboratory testing company with experience in performing sterilization for medical devices. This trocar device will be used to insert the implant subdermally. The trocar will have limited subdermal contact with patients- tissue. The successful Offeror for this RFP will perform the following: • Review of FDA comments on sterilization by a qualified person and determination of needed procedures according to FDA guidelines and ISO standards • Sterilization of trocars using Ethylene Oxide (EO) o a description of the sterilization method o a description of the sterilization chamber if not rigid, fixed; o the sterilization site; o the maximum levels of sterilant residuals that remain on the device, and an explanation of why those levels are acceptable for the device type and the expected duration of patient contact. • Validation of sterilization methods 1 SOW may be revised based on FDA feedback 2 o Submit a description of the method used to validate the sterilization cycle (e.g., the half-cycle method) but not the validation data itself. The submission should also identify all relevant consensus standards used and identify any aspects of the standards that were not met. In the absence of a recognized standard, a comprehensive description of the process and the complete validation protocol should be submitted and reviewed. • Certificate/assurance of sterility level o Provide assurance that the sterility level (SAL) is 10-6. • Assurance of endotoxin limit specifications o Submit a description of the method used to make the determination that the device meets pyrogen limit specifications (e.g., bacterial endotoxins test (BET)); o Submit a statement confirming that endotoxin testing will be conducted on every batch or if not, information regarding the sampling plan used for in- process testing and/or finished product release; o Submit identification of the chosen testing limit; and o Submit an explanation supporting the selected endotoxin limit. • Packaging of trocars into single use sterile packages o Provide a description of packaging and how it will maintain the device-s sterility. o Perform packaging integrity testing • Simulated shipping/environmental conditions and effect on package integrity o Complete simulated shipping distribution and associated package integrity, as well as simulated (and/or real-time) aging and associated seal strength testing, to validate package integrity • Complete test reports, summarizing the sterilization results and conclusions within 10 working days post test completion
• Documents:

 Tender Notice