Compounding Parenteral Products in Pediatric Wards—Effect of Environment and Aseptic Technique on Product Sterility

Parenteral products must be compounded using an aseptic technique to ensure sterility of the medicine. We compared the effect of three clinical environments as compounding areas as well as different aseptic techniques on the sterility of the compounded parenteral product. Clinical pharmacists and pediatric nurses compounded 220 samples in total in three clinical environments: a patient room, a medicine room and biological safety cabinet. The study combined four methods: observation, environmental monitoring (settle plates), monitoring of personnel (finger dab plates) and sterility testing (membrane filtration). Of the compounded samples, 99% were sterile and no significant differences emerged between the clinical environments. Based on the settle plates, the biological safety cabinet was the only area that fulfilled the requirements for eliminating microbial contamination. Most of the steps on the observation form for aseptic techniques were followed. All participants disinfected their hands, wore gloves and disinfected the septum of the vial. Non-contaminated finger dab plates were mostly detected after compounding in the biological safety cabinet. Aseptic techniques were followed relatively well in all environments. However, these results emphasize the importance of good aseptic techniques and support the recommendation of compounding parenteral products in biological safety cabinets in clinical environments.

Incidence of Adverse Reactions to Parenteral Thiamine in the Treatment of Wernicke’s Encephalopathy, and Recommendations

Aim To offer an estimate of the incidence of anaphylactic reactions to parenteral products containing thiamine used in the treatment of Wernicke’s encephalopathy (WE) and make recommendations. Method Review of previously released data on some older products and parenteral thiamine use in some other countries; analysis of sales and adverse incident data on anaphylaxis for a contemporary parenteral product used in the UK, Pabrinex. Results It was difficult to estimate the incidence of related anaphylactic reactions to Pabrinex in the UK because the number of doses given is unknown. Sales data are only an approximation to doses given because for products with a limited shelf life not all product sold is administered. However, available data indicate that there have been 10 anaphylactic reactions to Pabrinex from between 5,431,235–6,651,947 patient-days (14,880–16,080 years) of treatment. Conclusion It is reasonable to assume that the risk of anaphylaxis is low, and lower than for many other drugs. The risk-benefit ratio for administration is favourable given the potential severity of brain damage in Wernicke–Korsakoff (WK) syndrome. There is a need for international agreement on the reporting of anaphylaxis and on the optimum thiamine therapy for the treatment of WK syndrome. We make recommendations on how this might be achieved.

A Literature Study of IPQC (In Process Quality Control) tests and FDF (Finished Dosage Form) tests for Parenteral Dosage forms taking Adicovil IV Ampoule as an Example.

This study was conducted to evaluate both the in-process quality control tests as well as the finished dosage form tests for a parenteral product. Furthermore, all the processes from the purchase of API to marketing of product were studied. A batch of Adicovil was taken Adicovil was taken as an example, it is small volume parenteral of 2ml ampoule that is studied to evaluate its efficacy and stability by performing chemical and physical tests. IPQC tests for type I glass includes powder glass test, while for water for injection they are pH, acidity & alkalinity, non-volatile matter, ammonium ions, non-oxidizable matter, sterility and pyrogen test. Test for finished dosage form of Adicovil are identification, leaker test, clarity test, sterility, pyrogen test, BET, deliverable volume and determination of volume of injection for container. The selected batch of Adicovil passed all the IPQC and FDF tests in the procedure.