Sterile products

The objective in packaging cool sterilized products is to maintain the product under aseptic conditions, to sterilize the container and its Hd, and to place the product into the container and seal it without contamination. Contamination of the head space between the product and closure is avoided by the use of superheated steam, maintaining a high internal pressure, spraying the container surface with a bactericide such as chlorine, irradiation with a bactericidal lamp, or filling the space with an inert sterile gas such as nitrogen. [Pg.363]

Hemmerich, K. J., Polymer Materials Selection for Radiation-Sterilized Products, MD DI, Feb. 2000. [Pg.667]

Packaging Similarly, information on the closure/packaging systems must be provided in terms of material specification, suitability/compatibility with the pharmaceutical product, dimensional specifications, water impermeability, and so on. Defence against microbial contamination should be discussed in the context of either packaging of sterile product or use of preservatives as appropriate. [Pg.104]

Production and service provision - Operate production and service provision under controlled conditions, maintain batch records, validation processes that cannct be verified, maintain identification and traceability of materials, address specific requirements for sterile products, provide suitable conditions for storage and distribution... [Pg.232]

Brief description of ventilation systems. More details should be given for critical areas with potential risks of airborne contamination (schematic drawings of the systems are desirable). Classification of the rooms used for the manufacture of sterile products should be mentioned. [Pg.239]

This system is also used where an urgent product recall is required because of safety issues arising from quality problems during manufacture, for example a labelling mix up or the contamination of a sterile product. The authorities must be advised immediately of any situations where such action is contemplated, while a report on the effectiveness of the recall should be furnished at the end of the process. [Pg.258]

Sterilization of the finished drug delivery formulation is an important consideration often overlooked in the early design of lactide/glycolide delivery systems. Aseptic processing and terminal sterilization are the two major routes of affording an acceptably sterile product. Both of these methods are suitable for products based on lactide/glycolide polymers if proper care is exercised in processing or selection of the treatment procedures. [Pg.12]

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]

Gilbert P. Allison D. (1996) Redefining file sterility of sterile products. Eur JParenteral Sci, 1, 19-23. [Pg.409]

Staff should be trained in the principles of GMP and in the practice (and theory) of the tasks assigned to them. Personnel employed in the manufacture of sterile products (section 3) should also receive basie training in microbiology. [Pg.428]

Sterilization methods have been discussed in Chapter 20 and the various types of sterile products have been described in Chapter 21. For manufacturing purposes an important distinction exists between a sterile product which is termirrally sterilized and one which is not. Terminally sterilized means that, after preparation, the produet is transferred to containers which are sealed and then immediately sterilized by heat (or radiation or... [Pg.429]

Particulate, as well as microbial, contamination must be guarded against when sterile products are being manufactured. Thus, walls, ceilings and floors should possess smooth, impervious surfaces which will (i) prevent the accumulation of dust or other particulate matter and (ii) allow for easy and repeated cleaning and disinfection. For the same reasons, where walls and floors or ceilings meet, covings should be used. [Pg.430]

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]

Aseptically prepared products Terminally sterilized products (TSP) ... [Pg.432]

Table 22.2 Basic operating standards for the manufacture of sterile products... [Pg.433]

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