Instrument SOP - Pharma Egg

Jan32024 by XhaamiNo Comments

Classification of HVAC Systems in Pharmaceuticals

Instrument SOP, Microbiology, Production, SOPs

In the pharmaceutical industry, the proper control of temperature and air quality is essential for ensuring the quality, safety, and efficacy of products. Classification of HVAC Systems in Pharmaceuticals (heating, ventilation, and air conditioning) systems play a crucial role in maintaining the required conditions for pharmaceutical manufacturing, storage, and distribution. The HVAC system helps to maintain cleanroom conditions, regulate temperature and humidity levels, and provide fresh and filtered air. Pharmaceutical facilities often require a high level of control over environmental conditions to meet regulatory requirements, prevent contamination, and ensure product stability. The Classification of HVAC Systems in Pharmaceuticals is a critical component of the overall environmenta...

Jan32024 by KBS.No Comments

SOP for Operation Calibration and Cleaning of DT Apparatus

Instrument SOP, Quality Assurance, Quality Control, SOPs

If you are looking SOP for Operation Calibration and Cleaning of DT Apparatus then you are landed 0n the right page. In this blog post, we are going to share the process of Operation Calibration and Cleaning of DT Apparatus. It is the unique standard operating procedure Operation Calibration and Cleaning of Disintegration Apparatus equipment. After reading this article you will be able to understand the basic concept of cleaning equipment SOPs. PURPOSE: To lay down the procedure to perform the Operation, Calibration and Cleaning of DT Apparatus. This SOP is to establish guidelines for the proper operation, calibration, and cleaning of the disintegration apparatus to ensure accurate and reliable results in pharmaceutical disintegration testing. SCOPE of SOP for Operation Calibration an...

Dec92023 by KBS.No Comments

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...

Dec12023 by KBS.No Comments

General Instructions for Instruments in Pharmaceuticals (SOP)

Instrument SOP, General Topics, Quality Assurance, SOPs

General Instructions for Instruments in Pharmaceuticals (SOP) emphasizing the importance of proper instrument handling and usage to ensure accuracy, reliability, and safety. INTRODUCTION Identification and analysis of different product are made by different technique either by physical or chemical method, involving a specified machinery called Instrument are used at different stages of the product up to finished form. INSTRUMENTAL METHOD The method dependent upon measurement of an electrical property and those based upon determination of the extent to which radiation is absorbed or upon assessment of intensity of emitted radiation, all require the use of suitable instrument e.g. Polarimeter, Spectrophotometer etc. and in consequence such method are referred to as INSTRUMENTAL METHOD. E...

Dec12023 by KBS.No Comments

SOP for Installation Qualification Protocol and Formats

Instrument SOP, General Topics, Production, Quality Assurance, Quality Control

SOP for Installation Qualification Protocol and Formats is a critical phase in the validation process for equipment, systems, and utilities in regulated industries like pharmaceuticals, biotechnology, and medical devices. An IQ protocol is a document that outlines the procedures and criteria for the installation and verification of equipment. Below is an outline of an Installation Qualification Protocol along with suggested formats for key sections: INTRODUCTION Installation Qualification (IQ) is the process, which establishes through verification and documentation that the <Name of equipment> exists and is installed according to specification. Verification of appropriate documentation, such as, SOPs, drawings, repair parts lists, calibration methods, etc. for each piece of filter ...

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...

Nov22023 by KBS.No Comments

SOP for Calibration and Operation of Incubator

Instrument SOP, Quality Control, SOPs

This Statement of Purpose outlines the procedures and guidelines for the proper calibration and operation of the incubator at pharmaegg.com, SOP for Calibration and Operation of Incubator plays a crucial role in maintaining optimal conditions for various biological and chemical experiments. Adhering to strict calibration and operational protocols ensures accurate and reliable results, contributing to the overall scientific integrity of our research activities. PURPOSE To describe procedures for operation and calibration of Incubator. The primary objective of this SOP for Calibration and Operation of Incubator is to establish a standardized approach for the calibration and operation of the incubator. This SOP aims to guarantee the consistency and precision of experimental conditions, prom...

Nov22023 by KBS.No Comments

SOP for Operation of Air Sampler

Instrument SOP, General Topics, SOPs

This SOP for Operation of Air Sampler outlines the procedures for the proper operation of the air sampler to ensure accurate and reliable air quality monitoring within the [Your Organization Name] facility. PURPOSE To describe the procedure for the operation of the air sampler. SCOPE This procedure is applicable for the operation of an air sampler at the microbiological laboratory of QCD and the Manufacturing area. This SOP applies to all personnel responsible for operating the air sampler within the organization. RESPONSIBILITIES & AUTHORITIES It is the responsibility of microbiologist to follow this SOP as it is written It is the responsibility of QC manager to review and update this SOP as necessary and to ensure that this SOP is followed in its entirety. REFERENCES ...

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...