Ensuring that sterile and contamination free environments are maintained has become even more critical for manufacturers of sterile pharmaceuticals today due to the need to control the potential for cross contamination in drug manufacturing which is particularly important when dealing with the production of sterile drug products, Biologics and High-potency compounds. One of the primary technologi…
Showing posts with label Sterility. Show all posts
Difference Between Dynamic and Static Pass Box
In pharmaceutical manufacturing industries, pass boxes are normally used to transfer a particular material between two areas generally of different cleanliness levels. The boxes can be said to transfer the materials from a high level of cleanliness to a lower level of cleanliness or vice-versa. The pass boxes while transferring the material, help to prevent air from flowing from one area to anoth…
Cellulose Membrane Filters Used in Pharmaceuticals
Membrane filters are thin polymer films those have many microscopic pores. These filters have different pores sizes and used for different purposes accordingly. Membrane filters are used in various pharmaceutical activities. Cellulose filters are most commonly used filters in microbial analysis and reverse osmosis water systems. Most of the cellulose membrane filters are hydrophobic in nature.
SOP for Entering in Sterility Testing Room
1.0 Objective
To describe the procedure for entry in sterility testing room.
2.0 Scope This procedure is applicable whenever any person enters in sterility room for any work.
3.0 Responsibility 3.1 Doing: Lab. Assistant/Tech. Assistant (Microbiologist)/Executive
3.2 Checking: Executive/Manager
4.0 Accountability Head of the Department
5.0 Procedure 5.1 Remove the wristwatch and jewelry before ent…
2.0 Scope This procedure is applicable whenever any person enters in sterility room for any work.
3.0 Responsibility 3.1 Doing: Lab. Assistant/Tech. Assistant (Microbiologist)/Executive
3.2 Checking: Executive/Manager
4.0 Accountability Head of the Department
5.0 Procedure 5.1 Remove the wristwatch and jewelry before ent…
SOP for Sterility Testing
1.0 OBJECTIVE
To ensure the that batch of product is sterile or has been sterilized.
2.0 SCOPE This procedure is applicable to all parenteral pharmaceutical dosage forms and any specific material for which this test is mentioned in specification.
3.0 RESPONSIBILITY 3.1 Doing : Technical Assistant (Microbiologist)/Executive
3.2 Checking : Executive /Manager
4.0 ACCOUNTABILITY Head of the departm…
2.0 SCOPE This procedure is applicable to all parenteral pharmaceutical dosage forms and any specific material for which this test is mentioned in specification.
3.0 RESPONSIBILITY 3.1 Doing : Technical Assistant (Microbiologist)/Executive
3.2 Checking : Executive /Manager
4.0 ACCOUNTABILITY Head of the departm…
