Microbiology - Pharma Egg

Nov152023 by KBS.No Comments

Sterility Test Validation Standard Operating Procedure

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...

Nov82023 by KBS.No Comments

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.&...

Nov82023 by KBS.No Comments

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 ...

Nov72023 by KBS.No Comments

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...

Nov32023 by KBS.No Comments

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...

Nov32023 by KBS.No Comments

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...

Nov32023 by KBS.No Comments

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...

Nov32023 by KBS.No Comments

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 ...

Nov22023 by KBS.No Comments

SOP for Calibration and Operation of Cool Incubator

Instrument SOP, General Topics, Microbiology, SOPs

This Statement of Purpose outlines the procedures and guidelines for the proper SOP for Calibration and Operation of Cool Incubator at pharmaegg.com. The cool incubator is essential for maintaining low-temperature conditions for various biological and chemical experiments, making it crucial to adhere to strict calibration and operational protocols. Adhering to these protocols ensures accurate and reliable results, contributing significantly to the scientific integrity of our research activities. PURPOSE To describe procedures for operation and calibration of Cooled Incubator. The primary objective of this SOP for Calibration and Operation of Cool Incubator is to establish a standardized approach for the calibration and operation of the cool incubator. By following these guidelines, we ai...

Nov12023 by KBS.No Comments

SOP for Calibration and Operation of Top Balance

Instrument SOP, Microbiology, SOPs

PURPOSE This SOP describes procedure for the operation and calibration of top balance. SCOPE This SOP pertains to the handling of top balance in quality control laboratory. RESPONSIBILITIES & AUTHORITIES It is the responsibility of quality control analyst to follow this SOP for Calibration and Operation of Top Balance as written. It is the responsibility of QC manager to make certain that this SOP for Calibration and Operation of Top Balance is followed in its entirety and to review and update this SOP as necessary. REFERENCE & REQUIREMENTS Code of Federal Regulations, July 1, 1990.40 CFR part 160 Good Laboratory Practice Standards. DEFINITION & ABBREVIATIONS Calibration: Calibration means the set of operations that establish under specific conditions the rela...