Non-sterile products

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]

Failed USP dissolution test requirements Microbial contamination of non-sterile products Lack of efficacy Impurities/degradation products Lack of assurance of sterility Lack of product stability Labeling Label error on declared strength Misbranded Promotional literature with unapproved therapeutic claims... [Pg.53]

Materials required in the fabrication of equipment and associated systems dedicated to the production of pharmaceutical products should be capable of withstanding the temperature, pressure, and chemical corrosiveness of the product to ensure its purity and integrity. They also must meet a high degree of cleanliness to convey sterile and non-sterile products or solutions, particularly when it applies to their contact surfaces. Contact surfaces are all surfaces exposed to the product or from which liquids may drain, drop, or be drawn into the product, and solution contact surfaces are the interior surfaces of the circuit used exclusively for supply and recirculation of cleaning and/or sanitizing solutions. ... [Pg.2237]

Different types and levels of microbial control are applicable to different types of products. The single major division is between sterile and non-sterile products. [Pg.2286]

The Test for Sterility is vulnerable to false-positive and false-negative results. A false-positive means that a genuinely sterile product fails the test because of incidental contamination during the preparation of the sample or during the Test. A false-negative means that a non-sterile product passes the Test because viable contaminants fail to grow. [Pg.2288]

In setting appropriate limits for particular non-sterile products, both pharmacopeias take account of the significance of microorganisms to different types... [Pg.2294]

Requirements are not specified in the pharmacopeias for sample sizes appropriate to testing batches of non-sterile products for compliance with microbial limits. The test is destructive to the product, and it is extremely unlikely that statistically valid sampling plans are in use anywhere samples composed of 10 1-g amounts taken from 10 separate 15-g tubes of cream, or of three 3.3-ml amounts taken from three separate 500-ml bottles of syrup, may be typical. [Pg.2294]

The Microbial Limit Test is, like the Test for Sterility, only confirmatory. It is not generally mandatory to test each batch of every non-sterile product for compliance with microbial limits. The exception is in the United States where it is mandatory to test every batch of non-sterile product. At the time of writing (early 2001), the FDA has proposed a relaxation of this rule for future registrations. However, in the case of tablets there is no requirement to register microbial limits, and therefore testing is not mandatory. The logic behind this is that the water content of tablets is too low to allow proliferation of microbiological contaminants. [Pg.2294]

Water is often the major ingredient in non-sterile products. When it is used as an ingredient, it must meet the pharmacopeial limit for purified water of not more than lOOcfu/ml. Well designed and operated pharmaceutical purified water production and distribution set ups meet far tighter standards than these. Water is also often the principal cleaning fluid for equipment and facilities and is therefore unavoidable. It is a potent source of contamination because it usually contains sufficient nutrients to allow survival of metabolically versatile microorganisms, particularly Pseudomonas spp. [Pg.2295]

Maintenance of Microbiological Quality of Non-Sterile Products After Release... [Pg.2296]

It is not desirable for those few microorganisms that may be present in non-sterile products at the time of release to increase to numbers to levels at which they may present a risk of infection to the patient or spoil the product. [Pg.2296]

The inclusion of a routine Microbial Limit Test in a marketed product stability protocol will depend on the pharmaceutical dosage form. Typically, the test would be used for only non-sterile products, particularly oral liquids, nasal sprays and topical liquids, lotions and creams that have a sufficient water activity to support the growth of microorganisms. In contrast, tablets, powder and liquid-filled capsules, topical ointments, vaginal and rectal suppositories,... [Pg.2787]

Doors are generally rectangular, even though the chamber is cylindrical. In this case, the doors are inscribed in the circumference. There may be one or two doors two doors are always used when the autoclave leads into a sterile room. Two-door autoclaves are often used when this requirement does not apply, but the need is nonetheless felt to separate the loading area (where non-sterile products are placed) from the unloading area (where only already-sterilized products can be placed). The doors may be of various kinds. [Pg.3532]

Investigations carried out by the Swedish National Board of Health in 1965 revealed some startling findings on the overall microbiological quality of non-sterile products immediately after manufacture. A wide range of products was routinely found... [Pg.274]

Higher rates of contamination are invariably seen in products after opening and use and, among these, medicines used in hospitals are more likely to be contaminated than those used in the general community. The Public Health Laboratory Service Report of 1971 expressed concern at the overall incidence of contamination in non-sterile products used on hospital wards (327 of 1220 samples) and the proportion of samples found to be heavily contaminated (18% in excess of 104 CFU per g or per ml). Notably, the presence of Ps. aeruginosa in 2.7% of samples (mainly oral alkaline mixtures) was considered to be highly undesirable. [Pg.275]

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]

There are many definitions of quality (see Sharp, 2000). For the purpose of pharmaceutical products the term quality is usually taken to mean fitness for purpose. Not only must the product have the desired therapeutic properties it must also be safe for administration by the route intended. Some products such as injections must be sterile, while others such as oral drugs need not be sterile, but must be free from pathogens that can be contracted via the oral route (British Pharmacopoeia, 2003, Appendix XVID). A great deal more space in the literature is dedicated to quality of sterile products, but this reflects the additional quality assurance required compared with that for non-sterile products (Sharp, 2000). [Pg.376]

Sterilisation is the finite method for microbial control and can be achieved either by sterilising each component (product and packaging materials) followed by assembly, i.e. aseptic processing, or by a terminal sterilising process which involves both product and pack. The latter is the preferred method as it entails less risk of a non-sterile product being produced. [Pg.17]

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