Pharmaceutical Microbiology and Sterilization

Pharmaceutical microbiology, however, is concerned with the relatively small group of biological agents that cause human disease, spoil prepared medicines or can be used to produce compounds of medical interest. Common microorganisms to be checked during pharmaceutical products preparation are –

– Pseudomonas aeruginosa
– Staphylococcus aureus
– Escherichia coli
– Fungi
– Aspergillus niger
– Candida albicans

Sterile Preparation
A sterile preparation is described as the absolute absence of viable microbial contaminants. Certain pharmaceutical preparations, medical devices and items for which usage involves contact with broken skin, mucosal surfaces or internal organs, injection to the blood stream and other sterile parts of the body, are required to be sterile.

The majority of the processes recommended by pharmacopoeias (i.e. steam under pressure, dry heat, gaseous and ionizing radiation) are terminal sterilization processes for which the preparation is sterilized in its final container or packaging. For other multiple component preparations that cannot be sterilized with such methodologies, filtration sterilization can be used.

Pharma products to be sterilized:
– injections – intravenous infusions, total parenteral nutrition (TPN) fluids, small-volume injections and small-volume oily injections
– non-injectable sterile fluids – non-injectable water, urological irrigation solutions, peritoneal dialysis and hemodialysis solutions, inhaler solutions
– ophthalmic preparations – eye drops, lotions and ointments and some contact lens solutions
– dressings
– implants
– absorbable homeostats
– surgical ligatures and sutures (absorbable and non-absorbable)
– instruments and equipment – syringes, metal instruments, respirator parts, medical devices – endoscopes.

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