Sterility testing is a microbiology laboratory test that assesses if a product is free of viable microorganisms, or sterile. It’s performed on manufactured biological materials, such as blood products, pharmaceutical products, and sterile medical devices. The industry standard for sterility testing ...

1.Balance 2.Autoclave 3.Incubator 4.Laminar Air Flow/ Laminar Hood 5. pH Meter 6.Microscope 7.Water Bath 8. Hot air oven 9.Vortex Mixture/ Vortexer 10.Colony Counter 11.Spectrophotometer 12.Micropipette 13.Homogenizer 14.Air sampler 15.Deep Freezer 1.Balance Balance used for media preparation and MLT ...

Bacteria grow faster in the summer months because of the warmer temperatures and moisture. In fact, bacterial growth can be four to five times higher in the summer than in the winter. Most bacteria that cause disease grow fastest in the temperature range between 41 and 135 degrees F, which is known ...

A vacuum leak test is used to determine the air-tight integrity of a pre-vacuum autoclave’s chamber and plumbing system. A vacuum leak test is performed on an autoclave to check for any leakage. This test is also called a chamber integrity test. The test exposes the autoclave’s plumbing and ...

Validation of aspect processing should increase a process stimulation test using nutrient medium called media fill. A media fill is one part of the validation of an aseptic manufacturing process. The goal of a media fill is to test whether the aseptic procedure is adequate to prevent microbiological ...

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 – – ...

Pharmaceutical microbiology is the application of microbiology in pharmaceutical and healthcare environments. It is an applied branch of microbiology that recognizes that the extremely wide variety of microorganisms in the environment is fertile with potential, some for utility and others for danger. ...

Objectives: To set up a general and practical approach on safe microbiological practices for all persons involved with microbiological quality control. Scope: This SOP is applicable for all persons involved with the microbiological exercise in the laboratory. Resopnsibility: 1. All personnel involved ...

Objective: To provide a written procedure for the checks done in the Autoclave area prior to start-up. Scope: This SOP shall be applicable for Autoclave Area. Associated Documents: Form No. PP002-01, Daily Cleaning Report for General Production Area Responsibility: 1. ngineering Officer/Assistant Engineering ...

Microbiological test that evaluates the ability of aseptic manufacturing personnel to prevent contamination during drug production. The test uses a sterile microbiological growth medium, such as Triptic Soy Broth (TSB), to assess the technique and competency of personnel to perform tasks such as filling, ...