SECTION VIII: ANNEX D: MALE CONDOM INSPECTION, SAMPLING AND TESTING SPECIFICATIONS PRE-SHIPMENT TESTING

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1 SECTION VIII: ANNEX D: MALE CONDOM INSPECTION, SAMPLING AND TESTING SPECIFICATIONS PRE-SHIPMENT TESTING **Note: The WHO/UNFPA Specification is being reviewed for updates and this Annex is subject to changes** Prior to shipment each consignment of condoms shall be sampled by an independent inspection company appointed by UNFPA at the factory or manufacturer s warehouse, in accordance with ISO , the WHO/UNFPA Male Latex Condom Specification and the technical specifications that govern the respective agreement. These samples will then be tested by the independent testing laboratory, in accordance with the methods stated in ISO 4074 and the WHO/UNFPA Male Latex Condom Specification All testing activities will be conducted under ISO accreditation. The sample sizes used for testing shall be those specified in Annex A of ISO Testing for bursting pressure and volume after oven conditioning is not usually required. In the exceptional cases where oven-treatment is required, this will be expressly stated in the UNFPA Purchase Order. Annex III is prepared in accordance with ISO 4074, the WHO/UNFPA Male Latex Condom Specification Should there be discrepancy between Annex III, ISO 4074, and WHO/UNFPA Male Latex Condom Specification 2010, the highest and strictest requirements of the three will prevail. A. Dimensions and design Special Inspection Level S-2. Length: Measurement of condom length will be taken in accordance with the relevant clauses and annexes of ISO WHO/UNFPA specifies that the condom s minimum length, unless otherwise specified in the UNFPA purchase order, will be: 165 mm for condoms with widths of less than 50.0 mm; 180 mm for condoms with widths greater than or equal to 50.0 mm and less than 56.0 mm wide; 190 mm for condoms with widths equal to or greater than 56.0 mm. For the purposes of this test the width shall be measured at the narrowest part of the condom in the 1 For undated standards, the most recent edition will apply 2 WHO/UNFPA Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010

2 range 20 mm to 50 mm from the open end. The compliance level for each lot will be an AQL of 1.0. Test report: The test report shall reference the relevant clauses and annexes of ISO 4074 mean, maximum and minimum length and standard deviation of the tested samples, and the number of nonconforming condoms in the sample. Width: Measurement of condom width will be taken in accordance with the relevant clauses and annexes of ISO The width shall be measured at the narrowest part of the condom in the range 20 mm to 50 mm from the open end of the condom. Standard widths for public sector condoms are 49 mm or 53 mm. The required width will be specified in the UNFPA purchase order. A tolerance of ± 2 mm for individual condoms will apply. The compliance level for each lot will be an AQL of 1.0. Test report: The test report shall reference relevant clauses and annexes of ISO 4074 and the mean, maximum and minimum width and standard deviation of the tested samples, the number of nonconforming condoms in the sample and the point at which the width was measured. Wall thickness: Condom wall thickness shall be measured using a micrometer in accordance with the relevant clauses and annexes of ISO The wall thickness of condoms will be measured at three points: (30 ± 5) mm from the open end, (30 ± 5) mm from the closed end excluding the reservoir tip, and at the mid-distance between these two points. The individual measurements and the average of all three measurements will be recorded for each condom. Measurements will be taken with a micrometer (dial or digital types are acceptable) with a resolution of at least 0.001mm, a flat foot contact of diameter between 3mm and 7mm, and a foot pressure of (22 ± 5) kpa. For convenience of measurement, double wall thickness may be measured and divided by two. Before measurement, condoms will be wiped once, inside and out, with absorbent tissue. WHO/UNFPA specifies that the condom s mean single-wall thickness (calculated from the three individual measurements) for each condom will be ( ) mm, unless otherwise specified in the UNFPA purchase order. The compliance level for each lot will be an AQL of 1.0. Test report: The test report will include the elements of the relevant clauses and annexes of ISO 4074, as well as the mean, maximum and minimum thickness and standard deviation of the tested samples, and the number of nonconforming condoms in the sample. Shape and texture: Determination of shape and texture will be made by visual inspection, in 2

3 accordance with the WHO/UNFPA Male Latex Condom Specification The condom will be of natural colour, parallel-sided, without constrictions and with a visible shoulder leading to a reservoir tip, unless otherwise specified in the UNFPA purchase order. Colour: If a coloured condom is specified then the colour shall be verified by visual inspection. It is recommended that laboratories obtain reference condoms or colour swatches to facilitate inspection. Odour, fragrance and flavour: the condoms shall not give off an unpleasant odour when the package is opened (condoms have a characteristic rubber odour that tends to dissipate quickly; a mild odour that dissipates quickly once the package is opened is acceptable). If a fragrance or flavour is specified then verify that the condoms comply by inspection. Guidance on odour testing is given in Annex III of the WHO/UNFPA Male Latex Condom Specification It is recommended that laboratories obtain reference condoms to facilitate inspection. B. Quantity of lubricant Special Inspection Level S-2. Measurement of lubricant amount in the condom package will be made in accordance with the relevant clauses and annexes of ISO 4074 and the WHO/UNFPA Male Latex Condom Specification The total quantity of lubricant in a package, including powder, will be (550 ± 150) mg. The compliance level will be an AQL of 4.0. Note: WHO/UNFPA specifies that silicone fluid with a viscosity between 200 and 350 centistokes shall be used as the lubricant and a dusting powder such as corn starch, magnesium carbonate and/or calcium carbonate should be used to prevent the condoms sticking together during manufacture. The maximum recommended level of powder is 50mg per condom. C. Bursting volume and pressure test General Inspection Level G-1 for testing before and after oven conditioning (testing after oven conditioning for pre-shipment testing is subject to the conditions specified in the UNFPA Purchase Order and is not normally required). Testing will be performed in accordance with the relevant clauses and annexes of ISO

4 Note: For standard UNFPA orders, testing for bursting pressure and volume after oven conditioning is not required. In the exceptional cases where oven-treatment is required, this will be expressly stated in the UNFPA Purchase Order. The compliance level for each lot will be an AQL of 1.5 for non-conforming condoms. The minimum burst requirements for the condoms (both before and, if appropriate, after oven conditioning) will be as follows: Volume: 16.0 dm 3 for condoms with mid-body width less that 50.0 mm 18.0 dm 3 for condoms with mid-body width greater than or equal to 50.0 mm and less than 56.0 mm 22.0 dm 3 for condoms with mid-body width greater than or equal to 56.0 mm For the purpose of this test the mid-body width is the mean flat width of 13 condoms measured in accordance with ISO 4074 at a point (75 ± 5) mm from the closed end excluding the reservoir tip. Pressure: 1.0 kpa for all condoms Test report: The test report will include elements from the relevant clauses and annexes of ISO 4074 and the mean, maximum and minimum bursting pressure and bursting volume and standard deviations of the tested sample, and the number of nonconforming condoms in the samples. D. Freedom-from-holes and visible defects General Inspection Level G-1, but at least Code Level M. Condoms will be tested in accordance with the relevant clauses and annexes of ISO The compliance level for freedom-from-holes (the sum of condoms with visible and non-visible holes and tears) will be an AQL of The following will be considered non-compliers for holes: Condoms which burst during tests Condoms which break during mounting on the test head Condoms which show any evidence of leakage, including seepage, micro-droplets, and squirters. However, leakage within a distance of 25mm (1 inch) or less from the rim (open end) shall be disregarded. Condoms which have visible holes or tears before the water is added (including visible holes or tears less than 25mm from the rim). 4

5 The compliance level for critical visible defects is 0.4. The compliance level for non-critical visible defects is 2.5. Visible defects are defined on pages 41 and 42 of the WHO/UNFPA Male Latex Condom Specification, Prequalification, and Guidelines for Procurement, 2010 in Section One, Chapter 3: Workmanship and Visible Defects. E. Package integrity: Special Inspection Level S-3 Testing will be performed in accordance with the relevant clauses and annexes of ISO 4074, to check for possibility of breaches in sealed individual condom containers that may result in leakage of lubricant. The compliance level for each lot will be an AQL of 2.5. E.1 - Alternate test for shipments to high altitude countries *Note: This method is under review and is subject to modifications. 1. Principle of the dry vacuum method The condom packs are washed and dried, wrapped in coloured tissue, and put into U-shaped holders that prevent them from expanding. The U-shaped holders are placed in a vacuum chamber, which is evacuated for 20 minutes. The coloured tissue is examined for signs of staining. The packs are then examined, repacked and passed through the vacuum again, and the tissue re-examined. Packs are considered to be leaking if: 1. A stain appears on the first examination, and the stain is found to be larger on the second examination 2. No stain appears on the first examination, and one appears on the second examination. 5

6 2. Equipment required for the dry vacuum method The following equipment is required: 1. Ultrasonic cleaners with baths long enough to hold strips of 3 condoms (say 200 mm). If the baths not long enough, the strips it can be gently folded to fit. Note: it is necessary to ensure that the strips are submerged in the bath. This may be done by weighting the samples with a piece of metal (eg a large nut), or by using a frame that is part of the bath 2. Towels or tissues suitable for drying the packs (4 packs supplied) 3. Isopropanol for washing (technical grade) 4. U-shaped holders for condom strips (10 supplied) 5. Coloured tissue suitable for wrapping the strips, in order to show leakage stains (4 packs supplied) 6. Vacuum chamber (eg desiccator) capable of holding multiple U-shaped holders 7. Vacuum pump capable of evacuating the vacuum chamber to 20 kpa (absolute). Note: Manual washing may be used instead of the ultrasonic baths, provided that the process is shown to remove lubricant which can be embedded in the stamping of the seals, or in the serrations between packs. 3. Dry vacuum method For each Test ID (A, B, C and D): 1. Select 20 strips of 3 condoms each from the samples to be tested 2. Wash 10 strips in isopropanol in an ultrasonic bath for 10 minutes, ensure they are submerged (see page 3) Note: The isopropanol can be re-used until it looks dirty on visual examination 3. Remove the strips from the bath, and dry them with a paper towel 4. Place the strips on a clean dry paper towel for to air dry for at least 10 minutes 5. Ensure the strips are dry, then mark each individual strip with a reference number from 1 to Wrap each strip in one of the supplied coloured tissue then slide it into a U-shaped holder (refer to video for visual instructions on how to wrap the strips). 7. Place the U-shaped holders in a vacuum chamber and apply a vacuum of 20 ± 5 kpa (absolute). Hold at 20 ± 5 kpa (absolute) for 20 minutes, and release the vacuum. Note: if your laboratory is close to sea level, then 20 ± 5 kpa absolute is about -80 kpa gauge. 8. Remove the strips from the U-shaped holders one by one and check each tissue for stain marks. a. Using a fine pen, mark the perimeter of each stain on the tissue 6

7 b. Re-wrap the strip with the same tissue in the same place as before. Use the folds on the tissue to re-align the pack, or, if necessary, put guide marks on the tissue with a pen. Replace the strip in exactly the same orientation as it was prior. c. Record the number of leaks and their position into the spreadsheet, using the reference numbers of the strips. AQL 2.5 Over a transition period of 6 months to 1 year (for manufacturers), the AQL may be tightened to AQL 1.0, then to AQL 0.4 F. Individual package materials and markings: Special Inspection Level S-3. The sample of condom packages will be visually inspected to verify the required aspects of package quality. Quantitative tests to measure these parameters are not required, except for measurement of the thickness of the aluminium foil package if this is specified by the buyer or in the UNFPA purchase order. The compliance level for each lot will be an AQL of 2.5. The sample of condom packages is inspected for the following requirements: The colour, print design and identification marking, including Pantone references and font sizes, will be as specified by the UNFPA purchase order; Individual packages will be square or circular as specified in the UNFPA purchase order and will not distort the rolled condom. They will be hermetically sealed and shall protect the product form oxygen, ozone, water vapour, and ultraviolet and visible light; Unless otherwise stated in the UNFPA purchase order, the package will be constructed from a laminate which includes a layer of suitable impermeable flexible aluminium foil. The layers of plastic materials will be suitable for mechanical protection of the metal foil and for printing and sealing. If specified in the purchase order, the thickness of the aluminium foil (including laminate) will be verified by measurement using a micrometer. Any lot numbers and expiration dates will be printed on packages at the time of packaging, not pre-printed. In addition, the following will apply: There will be no evidence of leakage; The outside surface of the package will be clean and free from lubricant; There will be no separation of the layers of the laminate; 7

8 If the sealed packages are in strips, the individual packages will be separated by perforations which allow the packages to be separated by hand without interfering with the seals; The packages will be easy to open without damaging the condom; In addition, the visual inspection will verify that the identification marking on the packages is complete and correct, as specified by the UNFPA buyer or the UNFPA purchase order. The following particulars to be shown on the condom packages: Manufacturer s name and site address; Batch or lot identification code (printed at the time of packaging, not pre- printed); Month and year of expiry labeled Expiry Date in a language to be specified by the buyer (Month/Year, xx/xxxx); Month and year of manufacturing date, if specified in the UNFPA purchase order; Other information specified in UNFPA s purchase order. Test report: The test report will include the elements of the relevant clauses and annexes of ISO 4074, as well as the following particulars: The number of containers with detected leaks from air-bubbles; The number of containers with detected leaks of fluid inside the container. G. Inspection of Packing and Marking An inspection shall be performed to ensure that packaging, packing, and marking are in compliance with the requirements of WHO Male Latex Condom Specification, 2010 Section 2.4. The inspection shall be conducted in accordance with ISO For inspection related to the exterior shipping cartons, the sample unit shall be one exterior shipping carton. For inspections related to other parameters, the lot size shall be the number of inner boxes and the sample unit shall be one inner box. The inspection level shall be S-3, with an AQL of 2.5. Examination of inner boxes shall be performed on packages selected at random from sample shipping cartons. Examination of defects of closure shall be performed on randomly selected shipping cartons fully prepared for delivery. Preparation for delivery defects shall be scored in accordance with the Table below: Classification for Defects in Packaging and Marking: Examine Content Markings Materials Defects Number of condoms not as specified; packets or strips not as specified Omitted, incorrect, illegible, or of improper size, location, sequence, or method of application Packaging/packing materials not as specified, missing, 8

9 damaged or non-serviceable Workmanship Shipping cartons inadequately closed or secured; poor application of internal packaging and packing material; distorted intermediate packages H. Test report The condom testing report will be prepared in accordance with the relevant clauses and annexes of ISO 4074 and the UNFPA reporting template. Reports shall be supplied to UNFPA in electronic format with all required information clearly visible. 9