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Microbiology

Welcome to the Microbiology in Pharmaceuticals category! Here you’ll find articles exploring the essential role microbiology plays in the pharmaceutical industry. Learn how microbes like bacteria, fungi, and viruses are studied to develop new drugs and therapies. Discover how microbiological tests ensure drug safety and sterility. Read up on microbial fermentation processes used to manufacture antibiotics, insulin, steroids and more. Examine quality control methods like microbial limit testing for contamination

SOP for Operation of Autoclave Use in Pharmaceutical Industry

SOP for Operation of Autoclave Use in Pharmaceutical Industry

Instrument SOP, Microbiology, SOPs
A Standard Operating Procedure SOP for Operation of Autoclave Use in Pharmaceutical Industry is crucial to ensure the proper sterilization of equipment, materials, and products. Here's an example SOP outline for the operation of an autoclave. This example SOP serves as a general guideline. Adjustments should be made to align with the specific equipment and procedures within your pharmaceutical facility. Regular review and updates to SOPs are necessary to ensure compliance with current industry standards and regulations. PURPOSE To lay down a procedure for the operation of steam sterilizer (Autoclave). The objective of this SOP is to outline the proper procedures for the safe and effective operation of the autoclave to achieve sterilization of equipment, materials, and products in comp...
Sop for Cleaning, Mopping and Fumigation of Sterility Room

Sop for Cleaning, Mopping and Fumigation of Sterility Room

Microbiology, General SOPS, SOPs
Certainly! Below is a template for a Standard Operating Procedure SOP for Cleaning, Mopping, and Fumigation of a Sterility Room. This SOP is essential for maintaining a sterile environment in facilities such as pharmaceutical or biotechnology cleanrooms. Ensure that this SOP complies with any applicable regulatory guidelines and industry standards. Additionally, adapt the template to match the specific requirements and processes of your organization. Regularly review and update the SOP to reflect any changes in procedures or equipment. PURPOSE To describe the procedure for cleaning, mopping and fumigation of the sterility test Lab to avoid area / equipment generated Microbial contamination in sterility test Lab. SCOPE This procedure applies to sanitization by disinfecting mopping an...
Sterility Test Validation Standard Operating Procedure

Sterility Test Validation Standard Operating Procedure

Microbiology, General SOPS, SOPs
Sterility Test Validation Standard Operating Procedure is a crucial document that outlines the step-by-step process for validating the sterility testing procedures used in a pharmaceutical or biotechnology setting. This SOP ensures that the sterility testing methods are reliable, accurate, and consistent. Here's an outline that you can use to create an SOP for Sterility Test Validation: PURPOSE To assure that sterility test with direct inoculation will produce the same results when tested as per Sterility Test Validation Standard Operating Procedure. State the purpose of the SOP, which is to establish a standardized procedure for the validation of sterility testing methods. SCOPE This Sterility Test Validation Standard Operating Procedure is applicable for sterility of products. Define...
SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area

SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area

Microbiology, General SOPS, SOPs
PURPOSE To lay down a qualification SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area. The role of manufacturing department and quality control departments is to perform environmental monitoring. SCOPE This SOP for Personnel Qualification of Aseptic Area and Sterility Testing Area is applicable to Sterility testing area of microbiology lab and sterile injectable facility. The scope for aseptic processing is suitable for sterility testing field of sterile injectable capacity and microbiology laboratory. The SOP is mainly applied for the qualified individuals only for controlling the entry, exit and aseptic area gowning. RESPONSIBILITIES Microbiologist and all personnel are responsible to full fill the qualification requirements while entering sterile area.&...
SOP for BET Validation by Gel Clot Method

SOP for BET Validation by Gel Clot Method

Microbiology, General SOPS, General Topics, SOPs
Pharmaegg.com, I am writing this Statement of Purpose to outline the purpose and procedures involved in the validation of endotoxin testing using the Gel Clot Method as per the requirements of the United States Pharmacopeia (USP) and other relevant regulatory guidelines. I am committed to ensuring the accuracy, reliability, and reproducibility of endotoxin testing in our laboratory setting. Through this SOP, I aim to establish clear guidelines and protocols for the validation of the Gel Clot Method, a widely accepted technique for bacterial endotoxin testing (BET). PURPOSE This SOP for BET Validation by Gel Clot Method has been established to provide the guidelines for the validation of Gel Clot Method in Microbiological lab to ensure the quality and purity of lysate. This provides a ...
SOP for Preservative Efficacy Test

SOP for Preservative Efficacy Test

Microbiology, General SOPS, SOPs
A Standard Operating Procedure (SOP) for a Preservative Efficacy Test outlines the step-by-step process for conducting tests to determine the effectiveness of preservatives in cosmetic, pharmaceutical, and other products. This test is crucial to ensure that products remain safe and free from microbial contamination throughout their shelf life. Here's a sample SOP for a Preservative Efficacy Test: PURPOSE To provide guidelines for preservative efficacy test and determine the effectiveness of preservatives in products by assessing their ability to inhibit the growth of microorganisms. SCOPE This SOP for Preservative Efficacy Test is applicable for preservatives used for aseptic filling to inhibit the growth of microorganisms in product. This SOP applies to all personnel involved in condu...
Standard Operating Procedure (SOP) for Growth Promotion Test

Standard Operating Procedure (SOP) for Growth Promotion Test

Microbiology, SOPs
This SOP provides a United States Pharmacopoeia guideline for conducting a Growth Promotion Test. Always refer to specific pharmacopeial references and laboratory quality management system guidelines when performing the test for microbiological media used in specific applications. This Standard Operating Procedure (SOP) outlines the steps for conducting a Growth Promotion Test (GPT) to ensure the quality and performance of microbiological media used in the laboratory. Standard Operating Procedure (SOP) for Growth Promotion Test PURPOSE To describe the procedure for the growth promotion test of Medias used in Microbiology Lab for routine testing. SCOPE Procedure is applied to incoming Medias for microbiological tests. RESPONSIBILITIES AND AUTHOROTIES Manager Quality Control is r...
Standard Operating Procedure (SOP) for Preparation of Peptone Water

Standard Operating Procedure (SOP) for Preparation of Peptone Water

Microbiology, SOPs
This Standard Operating Procedure (SOP) outlines the steps for the preparation of Peptone Water, a common microbiological medium used for the cultivation and maintenance of a wide range of microorganisms. Standard Operating Procedure (SOP) for Preparation of Peptone Water PURPOSE This procedure has been established to provide the guidelines for preparation of Peptone Water. SCOPE This procedure is applicable to microbiological section of Quality Control Lab. RESPONSIBILITIES’ & AUTHORITIES Microbiologist is responsible for proper preparation of this culture media. Quality Control Manager is responsible for implementation of this SOP. REFERENCES & REQUIREMENTS Manufacturers COA USP general chapters DEFINITIONS & ABBREVIATIONS Dehydrated culture media: It is a mast...
SOP for Preparation of Fluid Thioglycollate Medium (FTM)

SOP for Preparation of Fluid Thioglycollate Medium (FTM)

Microbiology, SOPs
This Standard Operating Procedure (SOP) outlines the steps for the preparation of Fluid Thioglycollate Medium (FTM), a versatile enrichment medium used in microbiological laboratories for the cultivation and maintenance of anaerobic and microaerophilic bacteria. SOP for Preparation of Fluid Thioglycollate Medium (FTM) PURPOSE This procedure has been established to provide the guidelines for preparation of Fluid Thioglycolate Medium. SCOPE This procedure is applicable to microbiological section of Quality Control Lab. RESPONSIBILITIES’ & AUTHORITIES Microbiologist is responsible for proper preparation of this culture media. Quality Control Manager is responsible for implementation of this SOP. REFERENCES & REQUIREMENTS Manufacturers COA USP general chapter...
Standard Operating Procedure for Preparation of Tryptic Soya Broth

Standard Operating Procedure for Preparation of Tryptic Soya Broth

Microbiology, SOPs
This Standard Operating Procedure for Preparation of Tryptic Soya Broth outlines the steps for the preparation of Tryptic Soya Broth, a commonly used medium in microbiology for the cultivation of a wide variety of microorganisms. PURPOSE This Standard Operating Procedure for Preparation of Tryptic Soya Broth has been established to provide the guidelines for preparation of Tryptic Soy Broth. SCOPE This procedure is applicable to microbiological section of Quality Control Lab. RESPONSIBILITIES & AUTHORITIES Microbiologist is responsible for proper preparation of Standard Operating Procedure for Preparation of Tryptic Soya Broth culture media. Quality Control Manager is responsible for implementation of this Standard Operating Procedure for Preparation of Tryptic Soya Broth ...