Microbiological Quality of Injections Prepared in Hospital Pharmacies in Calabar, Cross River State

Extemporaneously prepared injectables in hospital pharmacy settings carry significant risk of microbiological contamination if appropriate aseptic compounding practices are not maintained. This study assessed the sterility and endotoxin content of injections prepared in the pharmacy departments of two tertiary hospitals in Calabar, Cross River State, South South Nigeria. Forty injectable preparations including antibiotics, electrolytes, and nutrient solutions were sampled over an eight-week period. Sterility testing was conducted in accordance with the British Pharmacopoeia using direct inoculation into thioglycollate broth and casein soya bean digest broth. Bacterial endotoxin testing was performed using the Limulus Amebocyte Lysate (LAL) gel-clot method. Environmental monitoring of laminar flow units and cleanrooms was conducted using settle plates and surface contact plates. Results indicated that 12.5 percent of preparations failed sterility tests, with Bacillus species and coagulase-negative Staphylococci as the predominant contaminants. Endotoxin levels exceeded acceptable limits in 7.5 percent of samples. Environmental monitoring revealed inadequate maintenance of laminar flow units, with colony counts exceeding ISO 14644 Grade A specifications. These findings raise serious patient safety concerns and highlight the need for investment in validated aseptic compounding infrastructure, mandatory training of pharmacy compounding staff, and regulatory inspections of hospital pharmacy environments. Keywords: injectable preparations, sterility testing, endotoxins, hospital pharmacy, Calabar.