validation
A Seminar on
Validation Of Sterilizing filter, Capsule filling machine & Integrated Lines
Prepared By Guided By: DAVE JAY Mr.RajeshParmar sir
M. Pharm QA, Sem – III
APMC COLLEGE OF PHARMACEUTICAL EDUCATION AND RESEARCH. (QA Department)
Equipment qualification
Equipment qualification / validation includes following things
User requirements specification (URS)
Design qualification (DQ)
Installation qualification (IQ)
Operational qualification (OQ)
Performance qualification (PQ)
Validation of sterilizing filters Sterile filtration processes are employed to sterile-filter a product prior to filling it aseptically into its final containers. Bulk drug solutions are sterile- filtered prior to aseptic crystallization, thus eliminating the possibility of having organisms within the bulk drug crystals.
The bulk drug can then be processed into a dosage form aseptically or further processed to be terminally sterilized. Other filtrative operations reduce the organism content of a final product prior to terminal sterilizations.
Filter media consist of a matrix of pores held in a fixed spatial relationship by a solid continuum. The pores allow the product solution to pass through the medium while retaining the unwanted solid particles and micro-organisms. The size of filter medium pores to retain micro-organisms must be quite small. The 0.20- or 0.22-µm pore size filter media are considered to be capable of producing sterile filtrates.
The important aspect of filtration sterilization, the membrane filter medium its pore size, pore size distribution, integrity, and capacity.
Nondestructive Physical Tests for Pore Size Characterization
The bubble point test is a popular single-point physical integrity test for disc filter membranes.
A filter medium is wetted with a
Validation Of Sterilizing filter, Capsule filling machine & Integrated Lines
Prepared By Guided By: DAVE JAY Mr.RajeshParmar sir
M. Pharm QA, Sem – III
APMC COLLEGE OF PHARMACEUTICAL EDUCATION AND RESEARCH. (QA Department)
Equipment qualification
Equipment qualification / validation includes following things
User requirements specification (URS)
Design qualification (DQ)
Installation qualification (IQ)
Operational qualification (OQ)
Performance qualification (PQ)
Validation of sterilizing filters Sterile filtration processes are employed to sterile-filter a product prior to filling it aseptically into its final containers. Bulk drug solutions are sterile- filtered prior to aseptic crystallization, thus eliminating the possibility of having organisms within the bulk drug crystals.
The bulk drug can then be processed into a dosage form aseptically or further processed to be terminally sterilized. Other filtrative operations reduce the organism content of a final product prior to terminal sterilizations.
Filter media consist of a matrix of pores held in a fixed spatial relationship by a solid continuum. The pores allow the product solution to pass through the medium while retaining the unwanted solid particles and micro-organisms. The size of filter medium pores to retain micro-organisms must be quite small. The 0.20- or 0.22-µm pore size filter media are considered to be capable of producing sterile filtrates.
The important aspect of filtration sterilization, the membrane filter medium its pore size, pore size distribution, integrity, and capacity.
Nondestructive Physical Tests for Pore Size Characterization
The bubble point test is a popular single-point physical integrity test for disc filter membranes.
A filter medium is wetted with a
References: 1. www.usvalidation.com 2. Berry I.R., and Nash R.A., ”Pharmaceutical Process validation” second edition, revised and expanded; Marcel Dekker series; 83-110 3. Pharmaguideline.blogspot.com 4. Media fill test by WHO 5. Syed Imtiaz Haider, “ Validation Standard Operating Procedures ” 314-321