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[The consideration and several suggestions on the national standard GB 7544 natural latex rubber condoms--requirements and test methods]
Zhongguo Yi Liao Qi Xie Za Zhi. 2010 Nov; 34(6):448-9.It was found that several problems exist in the implementation of GB 7544-2004 in the aspects of requirements of natural latex materials and safety of rubber condom products, microorganisms to be controlled and the packaging and label. As a result, the suggestions were put forward.
Bethesda, Maryland, University Research Company, Quality Assurance Project, 2004 Dec. 47 p. (QAP / WHO Field Report)The traditional approach to malaria diagnosis has been examination by microscope of a thick blood smear from the individual suspected of being infected. In an attempt to provide a more rapid alternative, companies worldwide have developed malaria rapid diagnostic tests (RDTs). Although RDTs can be effectively used in clinical settings by trained personnel, their greatest potential use is in rural areas with limited access to health and laboratory facilities. Using RDTs for diagnosis at the community level will shorten the delay between the onset of symptoms and the beginning of appropriate treatment. It will also slow development of resistance and lead to significant cost savings by avoiding unnecessary use of antimalarials. However, achieving a high level of sensitivity and specificity with RDTs in this context will require a product designed, labelled, and explained so that community health workers (CHWs) can use it accurately with minimal formal training and supervision. In partnership with theWHO Regional Office for the Western Pacific, the Quality Assurance Project (QAP) carried out quality-design research in the Philippines and the Lao People's Democratic Republic to develop and test a generic RDT job aid, mainly pictorial, that could be adapted with little modification for use with different RDT products and in different cultural settings by health workers with low literacy skills and with little or no prior training in product use. (author's)
BOLETIN OFICIAL DE LA REPUBLICA ARGENTINA. 1992 Nov 12; Sec 2(27513):5.This Resolution of the Ministry of Health of Argentina creates a National Register of Businesses manufacturing, packaging, and importing condoms and a Register of Devices, which has responsibility for the registration of condoms manufactured or imported into Argentina. Both Registers are under the control of the Directorate of Drugs, Medicaments, and Food. The Resolution also approves standards for testing condoms and places the Institute of Medicaments in charge of carrying out such testing to ensure the quality and safety of condoms. All businesses manufacturing, packaging, or importing condoms are required to register with the National Register and to petition the Register of Devices for approval of their condoms.
BOLETIN OFICIAL DEL ESTADO. 1991 Nov 29; (286):8102-13.Spain's royal decree 1688/1991 of November 22, 1991, establishes technical standards for condoms marketed in Spain and declares their approval obligatory. The technical specifications for characteristics and testing methods for condoms were defined in norm UNE 53-625-89, whose previously voluntary observation was declared obligatory by the 1991 decree. The specifications of UNE 53-625-89 are presented as an annex. The decree outlines the requirements and procedures for approval, to be granted by the General Office of Pharmacy and Health Products in accordance with the criteria spelled out in this decree. Packaging and product information requirements, regulations governing inspection, marketing, and advertising, and infractions and their sanctions are addressed as well. A form for requesting approval is included.
Standard specifications for rubber contraceptives (condoms). American National Standard ANSI/ASTM D 3492-77.
In: American Society for Testing and Materials [ASTM]. Annual book of ASTM standards. Part 38. Philadelphia, Pennsylvania, ASTM, 1980. 13-6.This document describes the requirements for condoms made of rubber latex intended for single use as specified by the American Society for Testing and Materials (ASTM) in 1977. Condoms must be manufactured from good quality rubber latex; they may be transparent, translucent, opaque, or colored. Condoms must not liberate toxic or otherwise harmful substances. The open end of condoms must end with an integral rim. 10 condoms out of a batch of 144,000 at most must be tested for design, including length, width, thickness, and mass or weight. Length must be from 160 mm to 180 mm +or- 10 depending on smooth or textured surface and on width; width must be from 49 mm to 52 mm +or- 2-3, again depending on type of surface; thickness must be 0.04 mm +or- 0.07-0.09, and maximum weight must be from 1.50 g to 1.95 g depending on smooth or textured surface. 25 condoms out of a batch of 144,000 at most must be tested for tensile properties, including tensile strength and elongation at breaking. Inspection for leakage must follow ISO 2859, General Inspection Level 1 for an acceptable quality level of 0.4%. Each condom must be filled with 300 cu cm of water and inspected for holes. Each condom must be marked with the manufacturer's name and date of manufacture. Every package must have name and address of manufacturer or distributor, and the name of the country of manufacture. Proper packaging should protect condoms for 10 years or more. Condoms should not be kept in storage longer than necessary, and should be stored in a cool place. One retest is possible before final rejection of lots not conforming to design and physical requirements. No retest is permissible for lots not conforming to test for quality assurance (leakage).
FDA: polyurethane condom carries "extremely misleading" label. Federal agency allows distribution for public health's sake.
CONTRACEPTIVE TECHNOLOGY UPDATE. 1995 Feb; 16(2):17-20.The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.
CONTRACEPTION. 1996 Apr; 53(4):221-9.Condoms from five manufacturers were subjected to controlled exposures of heat, humidity, and air and to different natural environments in five countries. Under aerobic conditions (condoms in permeable packages or unpackaged), stress properties declined. The relationship between rate of decline as a function of temperature was quadratic. Under oxygen-restricted conditions (foil-wrapped packages) at average storage temperatures of 30 degrees Celsius and lower, strain properties declined with little or no significant change in stress properties. The effect is to cause condoms to become stiffer; high-breakage rates in use have been correlated with product stiffening. A new rationale for accelerated-aging tests to predict condom shelf stability is suggested, including a test to control the trend of condoms to stiffen. Silicone lubricant, impermeable packaging, and inclusion of antioxidants in the condom formulation can prevent or minimize aerobic breakdown of latex condoms. Specifying low-modulus condoms can prevent excessive stiffening. (author's)
Worldwide regulatory requirements and their effects on the clinical study and transport of investigational new drugs.
DRUG INTELLIGENCE AND CLINICAL PHARMACY. 1977 Aug; 11(8):470-6.This article reviews regulatory requirements for the import, export, transport, and clinical study of investigational new drugs in those countries that make up the major pharmaceutical markets of the world. Regulations governing both human and veterinary drugs are discussed. The author states that the regulatory requirements on the extent and acceptability of clinical trial data are as diverse as the countries in which trials are conducted. He divides major pharmaceutical market countries into 3 groups. The 1st is made up of countries that accept foreign clinical studies for regulatory review; the 2nd of countries where local clinical trials are usually necessary for compliance with local regulatory requirements; and the 3rd (which includes India, Japan, and France) of countries where foreign data are not accepted and severe restrictions are placed on the importation of formulated clinical supplies for use in local clinical trials. The types of data that are required for investigational new drug approval are summarized for selected countries. Regulations on the transport of clinical drug supplies are discussed with a focus on whether countries require pretransport notification or documentation, the time factors involved in receiving approvals, whether authorized personnel or institutions are required to conduct clinical trials, and customs considerations. Particular attention is given to transport requirements in the U.S., the world's leader in controlling and regulating the transport and investigation of clinical drug supplies.
[Unpublished] . 3 p.This condom testing methodology covers the following: material, marking; sample size; dimensions; holes; bursting test; and aging test. Condoms shall be manufactured from good quality rubber latex. The condoms, along with any dressing applied to them, shall neither contain nor liberate substances known to be toxic or otherwise harmful under normal conditions of use. Any dressing shall not have a deleterious effect on the condom. Each condom or individual package in a batch shall have the same appearance and be uniformly and legibly marked with the manufacturer's identification mark and batch number and the recommended date (year and month) of expiration under normal conditions of storage. Each batch shall not exceed 1000 gross (144,000) condoms. From each batch, 450 condoms shall be sampled at random. The sampled condoms shall be divided into 3 parts: 10 condoms to be tested for dimensions in accordance with Clause 4; 300 condoms to be tested for holes in accordance with Clause 5; and 100 condoms to be tested for bursting capacity in accordance with Clause 6. The unrolled length (excluding any teat) shall exceed 16.0 cm. The single wall thickness, measured in the midbody portion of all samples, shall not exceed 0.007 cm. Each condom shall be unrolled, suspended freely from the rim, and filled with 300 ml of water. If no leakage is visible, the water filled condom shall be closed by twisting near the rim, dried on the outside, and lightly but firmly rolled in all aspects at least twice over dry absorbent paper which shall be inspected for the signs of leakage. Any holes detected shall be marked to indicate their position, the condom emptied of water and laid flat, and their distance from the closed end measured. The bursting test is to be performed on 1 in 10 only of the sample submitted. Fit a 3 liter flask above the constant head reservoir bulb and fill with water. Fit condom onto the end of the reservoir funnel about 38 cms above a platform. Add 3 liters of water to the condom. If it bursts, it fails. Accelerated aging shall be undertaken using an air oven. The condom samples shall be placed in the oven at a temperature of 70 degrees Centigrade for 168 hours. The specimens shall be removed from the oven and allowed to cool for not less than 12 hours. Specimens are filled to the reservoir bulb funnel about 38 cms above the platform. A 2 liter flask is filled to the reservoir and filled with water. The condom fails if it bursts immediately after the 2 liters of water is added.
[Unpublished] . 8 p.A study tour was undertaken by the Social Marketing Project in Bangladesh to observe production facilities of oral rehydration salt (ORS) in Bangkok, Manila, and Bombay. This report describes raw materials, plants and equipment, methods and procedures, and quality control for each country. In Thailand the Government Pharmaceutical Organization, under the Ministry of Health, supervises ORS production. ORS has been produced for the last 3 years and presently about 200,000 packets/month (equivalent of 1 litre solution) are being produced, following the World Health Organization (WHO) UNICEF formulations. The Ministry of Health in Manila has been providing ORS based on the WHO formulations for the past 6 years. Currently production is about 2 million packets with proper equipment. Distribution is through district health officials and village health workers. As an adjunct to ORS distribution there is a plan to introduce water purification tablets. The Fairdeal Corporation in India is a commercial pharmaceutical organization which produces 2 ORS solutions: 1) Electral which does not include bicarbonate and accounts for about 80% of total production, and 2) Electral Forte which has sodium bicarbonate and is recommended in severe dehydration cases in adults. Their research has shown that the WHO formulation is inadequate for many countries. Presently sales are about 500,000-600,000 packets/month mainly distributed through medical practitioners. This study also found that: 1) organic lipidity of the product is critical for acceptance; the addition of a flavoring agent is considered important especially for acceptance by small children, and 2) closely controlled humidity conditions (30-35%) and temperature (23 degrees Centigrade) are essential to the formulation and increases the life of the salts to 10-15 days even after opening the packs.
London, British Standards Insitute, 1979. 8 p.British Standard (BS) 3704, published in 1964 was one of the 1st standards dealing with the quality control of contraceptive devices. BS3704 had a 2nd edition in 1972, published to revise quality control techniques based on a cumulative sampling method applied to continuous production runs, to ensure that defective products did not exceed 0.5%. This document presents the 1979 revised edition of BS3704 with the requirements for condoms made of rubber latex. To test for design 1 specimen out of 10,000 must be tested for: 1) length, as determined by it being suspended over a graduate mandrel, which must not be less than 160 mm; 2) width, not less than 49 mm and not more than 56 mm; 3) thickness, no more than 0.160 mm for both smooth and textured condoms; and 4) weight, not more than 1.70 g for smooth and 1.90 g for textured condoms. 100 specimens over 10,000 must be tested for freedom from holes, as evidenced by the absence of leakage when filled with 300 ml of water and then rolled over absorbent paper. 10 specimens over 400,000, must be tested for tensile properties and for elongation at breaking point, and for color fastness. After each test a written test report is required. Rubber condoms must be packaged in sealed unit containers in such a way that the condoms are fully protected during transport and storage. Each individual container must carry the manufacturer's identification, batch number, number of contained condoms, and the date after which the condoms should not be used. Since rubber tends to deteriorate with age, condoms should not be kept in stock longer than necessary; as soon as a condom shows deterioration it should be destroyed.
Washington, D.C., Futures Group, 1983 Feb 14. 130 p.The process model developed in this paper for marketing analysis, planning, implementation, and control of contraceptive social marketing (CSM) programs is circular, with the last stage feeding back into the 1st. In the 1st stage, analysis, it is necessary to examine the market, the consumers, and the organization and structure within which the CSM program must operate. This includes geographical factors, distribution and sales outlets, local resources, behavioral factors, user status, media patterns, and staff resources. The 2nd stage, planning, involves setting marketing program objectives, market target segmentation, marketing mix strategies, identifying the media that will be used and establishing interpersonal contacts. The 3rd stage involves the development, testing, and refinement of plan elements. This involves the concepts and components of the products, distribution, pricing, concept and message communication, and program testing and training. Product tests concentrate on names, packaging, and logo. In the 4th stage, implementation, the full program is put into effect, requiring the implementing of the plan of action prepared in stage 2, monitoring marketing progress, and monitoring the institutional/structural performance of the CSM organization. As part of this step the communication elements of advertising, publicizing, and promotion must be activated. The 5th stage, in-market effectiveness assessment, can tell if the program is meeting its goals, any corrections which need to be made, and how the next cycle should be planned. At the 6th stage the monitoring and assessment is fed back into stage 1 to identify problems and revise the procedure. The author discusses the uses the methods of primary and secondary marketing research as well as qualitative and quantitative market research methods. The following types of research should be given priority: 1) research that will fill serious information gaps, 2) research that is most likely to be applied for marketing decision-making, 3) research that will reduce the risk of uncertainty associated with making major program changes, and 4) research that provides essential, periodic indicators of market response to ongoing program activities.