Procurement Services Branch Delivering supplies for reproductive health results Title: WHO/UNFPA Male Latex Condom Specification Date: September 29th 2014 WHO/UNFPA Specification for Male Latex Condoms, 2010 • • • • • • Part of “ Male Latex Condoms – Specifications, Prequalification and Guidelines for Procurement, 2010 Evolution from WHO specifications 2003 Edition alignment with ISO 4074 for technical requirements Corrigendum to ISO 4074 and proposed changes - 2010 edition Live document to relate to ISO 4074 Corrigendum to MLC specification published in April 2013 WHO/UNFPA Specification for Male Latex Condoms, 2010 Addresses: • Programme requirements – population , country needs • Donor requirements • Technical requirements Section 1 : Quality Assurance requirements Section 2 : Product specifications Linkage to Section 3 : Procurement aspects WHO/UNFPA Specification for Male Latex Condoms, 2010 Section 1: Quality Assurance • Specification/Buyer’s requirements • Supplier Prequalification • Regulatory Authorities • Manufacturing Quality Management • Sampling & Acceptable Quality Limit (AQL) - ISO 2859 WHO/UNFPA Specification for Male Latex Condoms, 2010 Section 1: Quality Assurance • Pre-shipment Compliance Testing • Monitoring Quality • Testing Laboratories and Accreditation • Testing Costs • Confirmatory Testing WHO/UNFPA Specification for Male Latex Condoms, 2010 Section 2: Specifications • Introduction • 2.1 General Requirements • 2.2 Performance Requirements • 2.3 Design Requirements • 2.4 Packaging for shipment WHO/UNFPA Specification for Male Latex Condoms, 2010 Section 2: Specifications • Table 1 Classification of defects • Table 2 Summary of prequalification tests and requirements • Table 3 Summary of Lot by Lot pre shipment compliance testing and requirements WHO/UNFPA Specification for Male Latex Condoms, 2010 2.1 General Requirements: • Safety of materials, condoms and manufacturing controls • Not liable for change Lot to Lot • Verification of documentation to support • Verification when significant changes are made design, materials, processes, equipment, packaging • Verification as part of prequalification WHO/UNFPA Specification for Male Latex Condoms- Section 2: Specifications 2.1 General Requirements: • Biocompatibility – ISO 10993 • Water extractable proteins - ISO 12243, EN 455-3, ASTM D 5172 - not more than 200 microgram per g. • Bioburden – Pharmacopoeia – not more than 100 cfu ((maximum of 500 cfu) and absence of pathogens such as Staph. aureus, E.coli, Ps.aeruginosa • Nitrosomines – steps taken by the manufacturer • Dusting powder – safe, not more than 50 mg WHO/UNFPA Specification for Male Latex Condoms- Section 2: Specifications 2.1 General Requirements: • Real time stability data at (30 +5, -2) 0 C • Provisional Shelf life : Not less than 3 years and not more than 5 years • Provisional Shelf life - verification – testing samples of 3 lots conditioning at 50± 2 0 C , 120 days – 3 years, 180 days – 5 years , based on burst properties, freedom from holes and package integrity • Minimum stability requirements as per ISO 4074 clause 7.2 • Sampling as per Annex B of ISO 4074 WHO/UNFPA Specification for Male Latex Condoms- Section 2: Specifications 2.2 Performance Requirements Lot by Lot quality verification by testing • Bursting volume and pressure ( oven conditioning -7/70 optional) • Freedom from Holes and visible defects • Package seal integrity WHO/UNFPA Specification for Male Latex Condoms- Section 2: Specifications 2.2 Performance Requirements Bursting volume and pressure • AQL – 1.5 • Minimum Pressure: 1.0 kPa • Minimum Volume: – 16.0 dm³ for widths < 50 mm – 18.0 dm³ for widths 50 mm up to 55.5 mm – 22.0 dm³ for widths ≥ 56 mm Note: the width is defined as the mean lay-flat width of 13 condoms measured at (75±5) mm from the closed end. WHO/UNFPA Specification for Male Latex Condoms- Section 2: Specifications 2.2 Performance Requirements Freedom from holes and visible defects • Freedom from Holes: AQL 0.25 – Test Methods: Hang/Roll; Hang/Squeeze; Electrolyte • Visible Defects: – Critical Defects – Non-Critical Defects • Visible Defects – Chapter 3 AQL 0.4 AQL 2.5 WHO/UNFPA Specification for Male Latex Condoms- Section 2: Specifications 2.2 Performance Requirements Critical visible defects • Pleat or Crease • Blister or Bubble • Coagulum (rubber particles) • Embedded and Surface Particles • Distorted Bead (rim) • Crack Marks • Thin Areas WHO/UNFPA Specification for Male Latex Condoms- Section 2: Specifications 2.2 Performance Requirements Non Critical visible defects • Small embedded and surface particle • Minor distortion of the rim – that does not compromise function • Uneven color (minor streaks) WHO/UNFPA Specification for Male Latex Condoms- Section 2: Specifications 2.2 Performance Requirements Other visible imperfections: • Micro coagulum • Flow Lines • Concave spot at the end of the teat • Distortion due to rolling of the condom • Bulges • Uneven coating of the lubricant WHO/UNFPA Specification for Male Latex Condoms- Section 2: Specifications 2.3 Design Requirements Programme related Agreed between manufacturer and procurement agency as per approved specimens Lot by lot verification by testing WHO/UNFPA Specification for Male Latex Condoms- Section 2: Specifications 2.3 Design Requirements • Shape and Texture • Integral Bead (rim) • Color • Odor, Fragrance, and Flavor • Dimensions • Lubricant and Powder • Individual Package Materials and Markings • Alternative Package Materials WHO/UNFPA Specification for Male Latex Condoms- Section 2: Specifications 2.3 Design Requirements • Shape and Texture: • • • • • • • Textured (ribs and dots) Smooth Surface Straight-wall (parallel sided) Contoured Flared Bulbous (wide body) Reservoir Tip WHO/UNFPA Specification for Male Latex Condoms- Section 2: Specifications 2.3 Design Requirements • Colour: Condoms can be Translucent or Colored Color pigments must be safe for use in medical devices, specifically latex condoms List of suitable pigments can be obtained through WHO, USFDA, etc. Material Safety Data Sheets – available from manufacturers • Odour, fragrance and flavourCondoms WHO/UNFPA Specification for Male Latex Condoms, 2010 Prequalification testing Prequalification testing : Freedom from Holes and Visible defect - before and after oven conditioning WHO/UNFPA Specification for Male Latex Condoms, 2010 Prequalification testing Package seal integrity before and after oven conditioning and sample size S-3 WHO/UNFPA Specification for Male Latex Condoms, 2010 • Lot by Lot Testing Package integrity - sample size S 3 Packaging and labeling: sample size S 3, AQL 2.5 WHO/UNFPA Specification for Male Latex Condoms 2010: Revisions in ISO 4074 : 2014 • Requirement of Biocompatibility testing and details as per ISO 10993. Cytotoxicity, irritation, sensitization • Visibly open seals inspection level G1 ( at least code letter M) – AQL 0.4 • Provisional shelf life based on accelerated stability studies at 500C aligned with UNFPA specification • Freedom from holes test: Electrolyte volume revised to 300 ml. Measurement of voltage from the first point of immersion, Hang and Squeeze method (ASTM) given as alternate method • Additional sizes and details in test methods • Recommendation to monitor bioburden, methods given in Annex G • Requirement of Clinical investigations to substantiate any special claims • Alternate method for determination of lubricant content – aqueous based • Micrometer method for determination of thickness described in detail • Tests for Freedom from holes and package seal integrity as part of stability studies Thank you!!
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