Microbiology

Role and Importance of Biological Indicators in Autoclave Validation

Role and Importance of Biological Indicators in Autoclave Validation

Byipharmacist

Autoclave validation is a critical process in pharmaceutical manufacturing to ensure effective sterilization. Among the various tools used, Biological Indicators (BIs) stand out as the gold standard for confirming sterilization efficacy. Why Biological Indicators Matter Biological indicators contain highly resistant microbial spores (e.g., Geobacillus stearothermophilus) that serve as a benchmark to validate whether the autoclave…

Pharmaceutical Microbiology and Risk Assessment

Pharmaceutical Microbiology and Risk Assessment

Byipharmacist

Pharmaceutical microbiology plays a critical role in ensuring the quality and safety of pharmaceutical products. Microorganisms can contaminate products, potentially harming patients and compromising product efficacy. Therefore, controlling and preventing contamination is essential to ensure product safety and this can be achieved through the process of Risk Assessment.Risk assessment is a systematic process that identifies,…

What is the Difference between the Microbial Limit Test and the Bioburden Test

What is the Difference between the Microbial Limit Test and the Bioburden Test

Byipharmacist

The Microbial Limit Test (MLT) and the Bioburden Test are both microbiological methods used to assess microbial contamination in pharmaceuticals, medical products, food products as well as in beverage industries. However, they differ in purpose, scope, and application. Purpose: Microbial Limit Test (MLT):Determines if a product meets specified microbial quality standards. Bioburden Test:Measures the total…

Setting of Alert and Action Limits for Microbial Monitoring

Setting of Alert and Action Limits for Microbial Monitoring

Byipharmacist

Alert and Action Limits are critical components of a microbial monitoring program, ensuring timely interventions to maintain control and prevent contamination. Here’s a step-by-step guide to calculate these limits: Alert Limit (AL): AL = μ ± (2-3σ) Action Limit (AcL): AcL = 0.8-0.9 × Maximum Acceptable Limit Example Calculation: Historical data (CFU/mL): | 10, 20,…

Why Use Less than One Instead of Zero CFU during Counting of Microbiology Samples?

Why Use Less than One Instead of Zero CFU during Counting of Microbiology Samples?

Byipharmacist

There are many reasons for using less than one (<1) cfu instead zero: Detection Limits Sampling Limitations False Sense of Security Risk Management Example: In a cleanroom where air samples are taken, if an active air sampler processes 1 cubic meter of air and no colonies are detected after incubation, the result is reported as…

What are ‘Log Reductions’ and Why are they Important?

What are ‘Log Reductions’ and Why are they Important?

Byipharmacist

In terms of infection control, ‘Log Reductions’ convey how effective a product is at reducing pathogens. The greater the log reduction the more effective the product is at killing bacteria and other pathogens that can cause infections. ‘Log’ is short for logarithm, a mathematical term for a power to which a number can be raised….

Bioburden and It’s Applications and Methods

Bioburden and It’s Applications and Methods

Byipharmacist

Bioburden is the term used to describe microbial contamination of a product prior to sterilization. Microorganisms can be introduced at any point during the manufacturing process through raw materials, the environment, humans, or during the final stage of cleaning and packaging. Since the sources of contamination can vary widely, a product’s bioburden can fluctuate from…

Settle Plate in Air Sampling

Settle Plate in Air Sampling

Byipharmacist

A settle plate is an agar plate, placed in a defined location. For consistency of sampling, for cleanroom it used in the pharmaceutical industry for semi-quantitative determination of microbial contaminations in the air. After four hours, they have undergone their maximum weight loss and should not be used for further examinations. Experiments showed that the…