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Manufacturing, pharmaceutical microbial contamination

Contamination. Manufacturers of cosmetics must be careful to guard against chemical and microbial contamination. Chemical contamination, which may result from the presence of undesirable impurities in raw materials, is avoidable by adhering to rigid specifications for raw materials. Compendial specifications and pubHcations by the CTFA and other professional societies form the basis of most intracompany raw material specifications. Moreover, all packaging components must meet not only physical and design specifications but also such chemical requirements as extractables and absence of dust and similar contaminants (see Packaging, cosLffiTics and pharmaceuticals). [Pg.288]

The first chapter in this section provides a unique account of the ecology, i.e. distribution, survival and life-style, of microorganisms in the factory environment, and should enable process designers, controllers and quality control personnel to comprehend, trace and eradicate the sources of failure due to extraneous microbial contaminants in the finished product. Much of the information given here is applicable to hospital manufacture also, and this is extended in a contribution (Chapter 19) dealing with contamination in hospital pharmaceutical products and in the home. [Pg.339]

As with traditional aseptic filling, in order to comply with pharmaceutical GMP, it is important to minimize contamination at all stages of manufacture. Raw materials should be of a high quality and tested for microbial contamination. Water used for product manufacture should be of low bioburden and high purity (preferably water-for-injection quality, although this requirement is dependent upon the nature of the product being manufactured). [Pg.4]

Monitoring pharmaceutical ingredients, water for pharmaceuhcal purposes, the manufacturing environment, and finished products submitted to the laboratory to demonstrate control of microbial contamination of the pharmaceutical products manufactured... [Pg.224]

In the general chapter on microbial attributes of nonsterile pharmaceutical products, the guidance suggests that the presence of microbial contaminants in nonsterile products [25] can reduce or inactivate the therapeutic activity of the product and has the potential to adversely effect the health of the patients and recommends manufacturers to ensure that contamination levels are as low as possible for finished dosage forms. Microbial enumeration limits for raw materials (total aerobic microbial count and total combined yeasts and molds count) and finished dosage forms are described. For inhalation, nasal, and topical routes of administration, tests for total aerobic microbial count and total combined and yeast and mold count,... [Pg.551]

Australian Pharmaceutical Manufacturers Association ( ) (1990), The Control of Microbial Contamination in Nonsterile Pharmaceutical Products for Human Use, , Canberra, Australia. [Pg.555]

The manufacture of biological products, unlike that of pharmaceuticals, uses materials that present variability. The active substance is generally produced in small quantities and needs to be separated from complex mixtures containing several types of contaminants. Lots are generally small and quality control tests are usually based on biological techniques that present higher variability than physicochemical assays. The processes are also susceptible to microbial contamination. The in-process controls are of fundamental importance to detect quality deviations that cannot be assessed through assays performed only on the final products. [Pg.351]

During development of the manufacturing process, an experienced microbiologist should be consulted as to the potential for microbial contamination of the product. Issues may include the selection of appropriate pharmaceutical ingredients, the ability of the manufacturing steps to control microbial contamination, the validation of sterilization processes, the cleaning and sanitization of process equipment, the adequacy of... [Pg.2784]

Preservatives. These are included in pharmaceutical preparations to prevent microbial spoilage of the product and to minimize the risk of the consumer acquiring an infection when the preparation is administered. Preservatives must be able to limit proliferation of microorganisms that may be introduced unavoidably into non-sterile products such as oral and topical medications during their manufacture and use. In sterile products such as eye-drops and multi-dose injections preservatives should kill any microbial contaminants introduced inadvertently during use. It is essential that a preservative is not toxic in relation to the intended route of administration of the preserved preparation. [Pg.286]

Sterile processing facilities require additional levels of sophistication. Active pharmaceutical ingredients manufactured for sterile use are required to be completed (usually the isolation/purification steps) in a sterile facility. The sterile facility is designed to minimize the exposure of the product from microbial contamination. [Pg.146]

Campaign manufacturing is common in pharmaceutical operations. If successive batches are being made of the same API, it is acceptable for residual materials to be carried from one batch into another, as long as there is adequate control. Adequate control will need to be determined for each API produced but minimally there must be assurance that degra-dants, microbial contaminants, or other sources of contamination are not carried from one batch to another. [Pg.261]

Healthcare facilities, schools, hotels, residences, food storage areas, and manufacturing facilities such as electronics, food, pharmaceuticals, and other at-risk material production areas need to have a reaction plan for avoidance and control of airbone and surface sourced microbial contaminants. Strategies for control of microbes must exist for garments, beddings, linens, wipes, surgical fabrics, and other textiles used in healthcare operations and construction materials. [Pg.57]

Downstream processing involves employment of a purifying system that can isolate the product in as few steps as possible using the simplest purification technology that will achieve the required purity. While purity is a critical consideration for both smaU-molecule pharmaceuticals and biopharmaceuticals, the nature of biopharma-ceutical administration (typically, at least to date, via injection) and the nature of biotechnology processes used in their manufacture require that additional considerations be paid to their purity. The final product must meet regulatory purity and sterility standards and must be below the maximally acceptable cellular or microbial contamination levels (Ho and Gibaldi 2003). [Pg.47]

Pharmaceutical products are used in a variety of ways in the prevention, treatment and diagnosis of disease, hi recent years, manufacturers of pharmaceuticals have improved the quality of non-sterile products such that today the majority contain only a minimal microbial population. Nevertheless, a few rogue products with an unacceptable level and type of contamination will occasionally escape the quality control net and when used may, ironically, contribute to the spread of disease in patients. [Pg.374]

Areas for the manufacture of sterile products are classified according to the required characteristics of the environment. Each manufacturing operation requires an appropriate level of microbial and particulate cleanliness four grades (Table 22.1) are specified in the Rules and Guidance for Pharmaceutical Manufacturers and Distributors (1997), defined by measures of airborne contamination (Table 22.2). Environmental quality is substantially influenced by the air supplied to the manufacturing environment. [Pg.432]


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