Healthcare Pharmaceutical Laboratory Analysis: Ensuring Safety and Quality in Medicinal Products and Formulations
In pharmaceutical and healthcare settings, various microbiological analyses and tests are conducted for regulatory purposes to ensure product safety and compliance with standards like USP (United States Pharmacopeia) and ISO (International Organization for Standardization). Here is a list of some common microbiological analyses and tests:
- Sterility Testing (USP <71>, ISO 11737-1): Determines the absence of viable microorganisms in a pharmaceutical product or medical device.
- Product Flush
- Membrane Filtration
- Microbial Enumeration Tests (Total Aerobic Microbial Count and Total Yeast and Mold Count) (USP <61>, USP <62>): Quantifies the total microbial load in a sample.
- Bioburden Testing (USP <61>, USP <62>, ISO 11737-1): Assesses the number and types of microorganisms present in raw materials, components, or finished products.
- Bacterial Endotoxin Testing (USP <85>, ISO 11737-3): Identifies and quantifies bacterial endotoxins using the Limulus Amebocyte Lysate (LAL) test.
- Growth Promotion Testing (USP <61>, USP <62>, ISO 11133): Ensures that culture media used in microbiological testing support the growth of specified microorganisms.
- Sterility Assurance Testing (ISO 17665-1): Validates the sterilization process for medical devices, pharmaceutical products, and their packaging.
- Biological Indicator Testing (USP <55>): Uses biological indicators, like spore strips or ampoules, to assess the effectiveness of sterilization processes.
- Biological Indicator – Spore Strip/Ampule
- Water Testing: Ensures the quality and microbiological purity of water used in pharmaceutical manufacturing (e.g., purified water, water for injection).
- Validation of Aseptic Processing (ISO 13408-1): Validates the aseptic processing and filling of sterile pharmaceutical products.