ANNEX III: MALE CONDOM INSPECTION, SAMPLING AND TESTING SPECIFICATIONS

Transcription

1 ANNEX III: MALE CONDOM INSPECTION, SAMPLING AND TESTING SPECIFICATIONS Prior to shipment, each consignment of condoms will be sampled by an independent inspection company appointed by UNFPA at the factory or manufacturer s warehouse, in accordance with ISO and the technical specifications that govern the respective agreement. The costs associated with the first inspection of each batch shall be borne by UNFPA. In the case of rejection, the cost of subsequent inspection(s) shall be borne by the male condom manufacturer. 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. Annex III is prepared in accordance with ISO 4074, the WHO/UNFPA Male Latex Condom Specification 2010 and UNFPA specific requirements for condoms. 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 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 less than 50.0 mm wide; 180 mm for condoms 50.0 to 55.5 mm wide; 190 mm for condoms equal to or wider than 56.0 mm. The compliance level for each lot will be an AQL of 1.0. Test report: The test report will include the elements of relevant clauses and annexes of ISO 4074 and the length of each tested condom. Width: Measurement of condom width will be taken in accordance with the relevant clauses and annexes of ISO 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 For undated standards, the most recent edition will apply 2 WHO/UNFPA Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010

2 Test report: The test report will include the elements of relevant clauses and annexes of ISO 4074 and the width of each tested condom, including the point, along the condom, at which the measurement was taken. Wall thickness: Measurement of condom wall thickness will be taken 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, and at the mid-distance between these two points. Lateral measurements made from the closed end will exclude the reservoir tip. 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 average calculated thickness of each tested condom. Shape and texture: Determination of shape and texture will be made by visual inspection, in accordance with the WHO/UNFPA Male Latex Condom Specification The condom will be of natural color, parallel-sided, without constrictions and with a visible shoulder leading to a reservoir tip, unless otherwise specified in the UNFPA purchase order. B. Quantity of lubricant 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 cornstarch, 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 Sampling and inspection: Sampling and inspection are performed in accordance with ISO , General Inspection Level G-1 for testing before and after oven conditioning.

3 Testing will be performed in accordance with the relevant clauses and annexes of ISO 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: Pressure: 16.0 dm 3 for condoms with widths less that 50.0 mm 18.0 dm 3 for condoms with widths from 50.0 mm up to but not including 56.0 mm 22.0 dm 3 for condoms with widths greater than or equal to 56.0 mm 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 bursting volume and bursting pressure of each tested condom. D. Freedom-from-holes and visible defects Sampling and inspection: Sampling and inspection are performed in accordance with ISO , 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) may 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). 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 as follows: Critical visible defects (AQL 0.4)

4 Defect Description Pleat/crease The film sticks to itself, and the pleat/crease cannot be removed by gentle stretching of the adjacent film. Blister/bubble An obvious circular or teardrop-shaped thin area with a well-defined border in the film (such defects may break under pressure). Coagulum (large) Rubber particles with any dimension greater than 1mm. These may cause the condom to fail in use. Embedded and Any particle with a dimension of 1mm or greater. These may be dirt, hair, insects etc.. surface particles Bead defects Faulty, missing or severely distorted beads (as in ISO 4074). Crack marks Lines that penetrate the surface of the film, formed by shrinkage of the latex during drying. These do not include flow lines or marks from the mould. Delamination Areas where the individual layers of latex separate (condoms are formed by two or more dips in the liquid latex). Thin areas Small areas of the condom (including the teat) that are visibly thin. These can show up as bulges with well-defined edges on the freedom-from-holes test. Condoms that look asymmetrical when filled with water are not necessarily in this category. Non-critical visible defects (AQL 2.5) Defect Embedded and surface particles (small) Faulty bead (minor) Uneven color Description Particles with dimensions less than 1mm that are visible to the naked or corrected eye. Uneven and partially distorted beads. Minor streaking. Occasionally, imperfections can be seen in condoms that do not affect the performance or acceptability of the product. No action should be taken when these imperfections are seen. Common imperfections are: Imperfections that are not regarded as defects Phenomenon Description Micro-coagulum Particles of rubber with dimensions less than 1mm. Flow lines Lines of denser material in the film. Concave spot at An apparent indentation caused during withdrawal of the former (dipping end of teat mould) from the latex. Distortion due to Apparent variations in condom width due to stretching during rolling. rolling Bulges Large bulges or distortion of the condom during the freedom-from-holes test that are due to differences in thickness around the wall of the condom caused by relative movement of the latex and the former (dipping mould) during dipping (these may or may not have well-defined edges). Uneven lubricant The open end of the condom may appear dry, especially on new condoms. The lubricant penetrates the roll slowly. Test report: The test report will include elements from the relevant clauses and annexes of ISO 4074 and the following particulars: The number of condoms exhibiting a visible hole or tear before mounting on the apparatus;

5 The number of condoms exhibiting a voltage equal to or greater than 50mV (in the case of electrical tests); The number of condoms with leaks observable on the apparatus which, when measured, are located more than 25mm from the open end; The number of condoms which show signs of leakage on rolling, which, when measured, are located more than 25mm from the open end; The number of condoms with visible defects other than holes or tears, and the nature of the defects. E. Package integrity: 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. F. Individual package materials and markings: 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 aluminum foil package. The compliance level for each lot will be an AQL of 2.5. The sample of condom packages is inspected with the following requirements: The color, 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 vapor, 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 aluminum foil. The layer of each aluminum foil will have a minimum thickness of 8 micrometers. The layers of plastic materials will be suitable for mechanical protection of the metal foil and for printing and sealing. The thickness of the aluminum foil (including laminate) will be verified by a micrometer. However, UNFPA looks

6 forward to the testing laboratory s expertise on measurement of foil only or foil with laminate, depending upon the available technology; 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; 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. WHO requires the following particulars to be shown on the condom packages: Manufacturer s name; 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. Test report The condom testing report will be prepared in accordance with the relevant clauses and annexes of ISO H. 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 Model Specifications Section 3.4. 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:

7 Examine Content Markings Materials Workmanship 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, damaged or non serviceable Shipping cartons inadequately closed or secured; poor application of internal packaging and packing material; distorted intermediate packages