Sterilization is an essential operation in pharmaceutical manufacturing, particularly when it comes to sterile products. Impacting directly upon patient safety, contamination control is of utmost importance at sterile product facilities. Within the entire spectrum of methods used to sterilize materials for use in the pharmaceutical industry, autoclaving (steam sterilization) is presently accepted…
Showing posts with label Sterilization. Show all posts
Validation of Biological Indicators for Sterilization
One of the most important processes in the manufacture of pharmaceuticals is sterilization, especially for products intended to be sterile. The success of this sterilization will have a direct impact on the safety, quality and ultimately health of the product(s) being manufactured. The use of Biological Indicators (BIs) is a preferred method for the pharmaceutical industry to verify that they are…
Validation of Pure Steam in Pharmaceuticals
Pharmaceutical manufacturing relies heavily on pure steam, particularly in sterile pharmaceutical manufacturing. Pure steam is largely used to sterilize apparel, pipelines and all components, as well as directly and indirectly contacting product contact surfaces; therefore, it must meet exacting standards.
Autoclave Validation in Pharmaceuticals
In pharmaceutical manufacturing facilities, sterilization is one of the most critical processes. Any error in sterility testing can compromise product quality and patient safety. From all sterilization techniques, moist heat sterilization is commonly used method for pharmaceutical articles because of its reliability, efficiency and cost effectiveness.
Low Temperature Sterilization Process (115°C) and Its Validation
Sterilization of the media and material is generally done at 121 °C but sometimes it is required to do at low temperature (115 °C) because of heat sensitivity of the material. This sterilization below 121 °C is called Low-Temperature Sterilization.
SOP for Steam Penitration Study by Bowie-Dick Test
1.0 Objective
To study of steam penetration evenly in double door Autoclave with use of Bowie-dick type test kit.
2.0 Scope This procedure is applicable to study even and rapid steam penetration in Double door Autoclave.
3.0 Responsibility 3.1 Doing : Technical Assistant/Executive
3.2 Checking : Executive/Manager
4.0 Accountability Head of the Department
5.0 …
2.0 Scope This procedure is applicable to study even and rapid steam penetration in Double door Autoclave.
3.0 Responsibility 3.1 Doing : Technical Assistant/Executive
3.2 Checking : Executive/Manager
4.0 Accountability Head of the Department
5.0 …
SOP for Cleaning of Autoclave
1.0 OBJECTIVE
To lay down the cleaning procedure of autoclave.
2.0 SCOPE This procedure is applicable for cleaning of Autoclave
3.0 RESPONSIBILITY 3.1 Doing: Lab Asst./Technical Assistant
3.2 Checking: Technical Assistant/Executive
4.0 ACCOUNTABILITY Head of the Department
5.0 PROCEDURE 5.1 After the completion of cycle unload the autoclave.
5.2 Then shut the door II of the sterile side.
5.3 Op…
2.0 SCOPE This procedure is applicable for cleaning of Autoclave
3.0 RESPONSIBILITY 3.1 Doing: Lab Asst./Technical Assistant
3.2 Checking: Technical Assistant/Executive
4.0 ACCOUNTABILITY Head of the Department
5.0 PROCEDURE 5.1 After the completion of cycle unload the autoclave.
5.2 Then shut the door II of the sterile side.
5.3 Op…
SOP for Operating Procedure of Double Door Autoclave
1.0 OBJECTIVE
To lay down the step by step procedure for operating the Autoclave.
2.0 SCOPE This procedure is applicable for operating the double door autoclave.
3.0 RESPONSIBILITY 3.1 Doing : Lab Asst./Technical Assistant/Executive
3.2 Checking : Technical Assistant/Executive/ Manager
4.0 ACCOUNTABILITY Head of the Department
5.0 PROCEDURE MAKE :
MODEL NO.:
For Automode
5.1 Switch ‘ON’ the WFl pump…
2.0 SCOPE This procedure is applicable for operating the double door autoclave.
3.0 RESPONSIBILITY 3.1 Doing : Lab Asst./Technical Assistant/Executive
3.2 Checking : Technical Assistant/Executive/ Manager
4.0 ACCOUNTABILITY Head of the Department
5.0 PROCEDURE MAKE :
MODEL NO.:
For Automode
5.1 Switch ‘ON’ the WFl pump…
SOP for Validation of DHS with Biological Indicator
1.0 Objective
To validate DHS with the biological indicator for sterilization efficiency.
2.0 Scope This procedure is applicable for DHS, installed in microbiology area of quality control laboratory.
3.0 Responsibility 3.1 Doing: Tech.Assistant ( Microbiologist)
3.2 Checking: Executive/Manager
4.0 Accountability Head of the Department
5.0 Procedure 5.1 Frequency: At every six month
5.2 Organism:…
2.0 Scope This procedure is applicable for DHS, installed in microbiology area of quality control laboratory.
3.0 Responsibility 3.1 Doing: Tech.Assistant ( Microbiologist)
3.2 Checking: Executive/Manager
4.0 Accountability Head of the Department
5.0 Procedure 5.1 Frequency: At every six month
5.2 Organism:…
