Parenteral preparations sterilisation

For infusion bags PVC and PP are used. PVC- as well as PP-bags can be steam sterilised. Infusion bags have to meet the requirements of the Ph. Eur. for containers for parenteral preparations [32]. The Ph. Eur. also describes a test for the release of phthalates (plasticisers) from the PVC. This test has limitations and does not seem to predict every practical situation in practice the release may be much higher than is predicted by this test [40]. 

Microbiological contamination of the starting material should be minimal to make sterilisation as effective as possible. Premises for preparation of parenteral products are classified as described in Sect. 27.4.1. 

For irrigatiOTis steam sterilisation in its final container for 15 min at 121 °C (see Sect. 30.5.1) is preferred. These are the same requirements as for parenteral solutions. An aseptic preparation method with bacterial filtration through a 0.2 pm filter, followed by heating at 100 C for 30 min (or another proper combination of temperature and time or validated aseptic conditimis) is an alternative when one of the substances is sensitive to a higher temperature. If an active substance is not heat resistant at all, only an aseptic preparation with bacterial filtration over a 0.2 pm filter is possible. In such cases the starting materials should be sterile or have a low bioburden and the irrigation should be prepared asep-tically. See also Sect. 30.6. 

Finished parenteral products prepared in the radiopharmacy department must be sterile. Based on a risk analysis one may conclude that the risk of non-sterility is very low for standard radiopharmaceutical kit preparations. The risk of contamination is somewhat higher for the eluate from radionuclide generators, especially when they are used for a long period. The injection bottle on top of a Tc generator (sterile sodium chloride solution for injection) is changed asepti-cally each day however, the inside of the generator system is not sterilised nor disinfected. For that reason it is recommended to control the microbiological quality of the... 

As an example, the process of the preparation of parenteral solutions in ampoules and its validation are elaborated. In Table 34.2, the process from weighing the ingredients to sterilisation of the ampoules is displayed stepwise. During the validation of this process there is referral to the following external factors that need to be qualified or calibrated ... 

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