Compounding sterile products testing

The production test showed that the epoxy phenolic enamel was the preferred enamel for coating tinplate containers used in packaging irradiation-sterilized ham and beef. The preferred end-sealing compound for the same application was the blend of cured and uncured isobutylene-isoprene copolymer. 

Several guidelines are available in the literature for the pharmacist who must extemporaneously prepare an ophthalmic solution. The USP contains a section on ophthalmic solutions, as do other compendia and several standard textbooks. Since the pharmacist does not have the facilities to test the product, he or she should dispense only small quantities, with an expiration date of no more than 30 days. Refrigeration of the product should also be required as a precautionary measure. To reduce the largest potential source of microbial contamination, only sterile purified water should be used in compounding ophthalmic solutions. Sterile water for injection, USP, from unopened IV bottles or vials is the highest-quality water available to the pharmacist. Prepackaged sterile water with bacteriostatic agents should not be used. 

Simulated use tests involve deliberate contamination of instruments, inanimate surfaces, or even skin surfaces, with a microbial suspension. This may either be under clean conditions or may utilize a diluent containing organic (e.g. albumin) material—dirty condition. After being left to dry, the contaminated surface is exposed to the test disinfectant for an appropriate time interval. The microbes are then removed (e.g. by rubbing with a sterile swab), resuspended in suitable neutralizing medium, and assessed for viability as for suspension tests. New products are often compared with a known comparator compound (e.g. 1 minute application of 60% v/v 2-propanol for hand disinfection products— see EN1500) to show increased efficacy of the novel product. 

In the case of Tc pharmaceuticals, chemistry and safety have been compounded into kits, which have overcome the limitations set by radioactive decay and the risk of bacterial contamination. Kits are manufactured in advance in accordance with GMP requirements for the manufacture of sterile medicinal products, have a long shelf life, and facilitate ad hoc labeling whenever there is a demand in nuclear medicine. Kits provide safety and ease of preparation of highly complex molecules by using aseptic techniques for labeling. Consequently, quality control requirements for kit preparations rely merely on testing the radiochemical purity of a " Tc pharmaceutical to demonstrate stability in compliance with the purity requirements stated in the pharmacopeia. 

One problem that may arise is when an antibiotic or preservative is the product, or part of the product under test. When this happens, the material must be inactivated or removed before sterility testing can take place. There are several methods of achieving this. Antibiotics, such as the penicillins, may be inactivated by the addition of the enzyme P-lactamase, whilst the action of sulphonamides can be blocked by the addition of />-aminobenzoic acid. Products containing preservatives or antimicrobial agents, such as benzoic acid, alcohols, or phenols, are diluted to the level at which the compound becomes ineffective. Products containing quaternary ammonium compounds can be inactivated by the addition of Tween, whilst many compounds containing heavy metals can be... 

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