⢠Validation for Environmental Monitoring
™
BRASS
Validation for Environmental Monitoring
A service that developed from years of experience and customers’ needs, BRASS presents the availability of customized onsite evaluation of production cleanrooms for medical products manufacturing and microbial monitoring studies of production facilities.
Validation for Environmental Monitoring
Before Routine Environmental Monitoring Evaluating the microbial quality of air and surfaces in the cleanroom environment should start with a well-defined written program and validated methods. BRASS™ ensures that your current Good Manufacturing Practice (cGMP) compliance needs are met. We provide a comprehensive evaluation of your clean and controlled manufacturing facility to justify the routine testing methodology, best practices and baseline microbial attributes of your production areas. Before embarking on routine environmental monitoring, our facility validation experts will provide you with study plan based on the following assessment: • • • • • •
Description of process objective and work environment Identification of Critical Areas Hypothesis of all possible microbial hazards Evaluation of probability and severity of a risk, with a given hazard value Recommendation of controlling and monitoring measures for high hazard processes Setting Alert and Action Levels
Evaluation and Interpretation of Results We provide more than testing The US FDA requires trend analysis of environmental microbial data and BRASS provides this very compliance program that identifies potential routes of contamination, and allows for implementation of corrections before product contamination occurs. BRASS Trend Analysis service establishes microbiological monitoring limits and their relationship with the manufacturing location. Our trend reports include specialized development of Alert and Action limits
Risk Management We provide guidance in incorporating microbiological risk management into your quality objectives According to the US FDA, risk management is the overall and continuing process of minimizing risks throughout a product’s lifecycle to optimize its benefit/risk balance. BRASS places your environmental monitoring data in the context of programs that minimizes the risk of process or product failure, through: • • •
Risk Management Planning and Programs Risk Assessment Evaluation and revision of interventions ®
E-mail: enquiries@brass-asiapacific.com Website: http://www.brass-asiapacific.com
Biomedical Research and Support Services Pte Ltd
™
BRASS
STERILIZATION ASSURANCE
Our laboratory offers testing, knowledge and support in Sterilization Process Validation studies in conformance with Pharmacopoeia, ISO, AAMI and other international standards.
•
Ethylene Oxide (EO) Sterilization
•
Radiation Sterilization
•
Steam Sterilization
STERILIZATION ASSURANCE
RADIATION STERILIZATION Our ISO11137 Certificate of Compliance summarizes your quarterly Radiation Sterilization bioburden evaluation and dose verification data to support your audit programmes. • • • • •
Bioburden Validation 3-Lot Bioburden Analysis Dose Verification Sterilization Dose Establishment Quarterly Dose Audit
ETHYLENE OXIDE AND STEAM STERILIZATION Installation Qualification (IQ) and Operational Qualification (OQ) of Chamber BRASS™ shall gather objective evidence to ensure that the sterilization chamber has been installed correctly through installation qualification (IQ) and challenge the process parameters to assure that the sterilization chamber meets all defined requirements under all anticipated conditions of sterilization through operational qualification (OQ). Copies of the chamber supplier qualification studies should be used as guides, to obtain basic data, and to supplement the IQ study. During the OQ study, process parameters shall be measured in order to maintain a state of control.
PHYSICAL PERFORMANCE QUALIFICATION BRASS shall gather objective evidence to demonstrate that the sterilization process will consistently produce acceptable results under normal operating conditions. The time, temperature, humidity, pressure and sterilant concentration parameters shall be determined.
Microbiological Performance Qualification METHOD A: SURVIVOR CURVE CONSTRUCTION The lethality of the sterilization cycle shall be determined by construction of a survivor curve using direct enumeration of survivors. METHOD B: FRACTION NEGATIVE METHOD The exposure time required to achieve a specified probability of the survival of the test organism shall be calculated from the D-value. METHOD C: HALF-CYCLE METHOD The minimum exposure time required at which there are no survivors is achieved. The routine cycle should be twice the exposure time.
Method
TABLE 1: Variations in Information Obtained from Different Sterilization Validation Methods
A
B
C
Cycle Development
YES
YES
YES
Sterility Assurance Level (SAL)
YES
YES
NO
D-value
YES
YES
NO
Overkill
YES
YES
YES
® E-mail: enquiries@brass-asiapacific.com Website: http://www.brass-asiapacific.com
Biomedical Research and Support Services Pte Ltd
BRASS
Validation for Environmental Monitoring
A service that developed from years of experience and customers’ needs, BRASS presents the availability of customized onsite evaluation of production cleanrooms for medical products manufacturing and microbial monitoring studies of production facilities.
Validation for Environmental Monitoring
Before Routine Environmental Monitoring Evaluating the microbial quality of air and surfaces in the cleanroom environment should start with a well-defined written program and validated methods. BRASS™ ensures that your current Good Manufacturing Practice (cGMP) compliance needs are met. We provide a comprehensive evaluation of your clean and controlled manufacturing facility to justify the routine testing methodology, best practices and baseline microbial attributes of your production areas. Before embarking on routine environmental monitoring, our facility validation experts will provide you with study plan based on the following assessment: • • • • • •
Description of process objective and work environment Identification of Critical Areas Hypothesis of all possible microbial hazards Evaluation of probability and severity of a risk, with a given hazard value Recommendation of controlling and monitoring measures for high hazard processes Setting Alert and Action Levels
Evaluation and Interpretation of Results We provide more than testing The US FDA requires trend analysis of environmental microbial data and BRASS provides this very compliance program that identifies potential routes of contamination, and allows for implementation of corrections before product contamination occurs. BRASS Trend Analysis service establishes microbiological monitoring limits and their relationship with the manufacturing location. Our trend reports include specialized development of Alert and Action limits
Risk Management We provide guidance in incorporating microbiological risk management into your quality objectives According to the US FDA, risk management is the overall and continuing process of minimizing risks throughout a product’s lifecycle to optimize its benefit/risk balance. BRASS places your environmental monitoring data in the context of programs that minimizes the risk of process or product failure, through: • • •
Risk Management Planning and Programs Risk Assessment Evaluation and revision of interventions ®
E-mail: enquiries@brass-asiapacific.com Website: http://www.brass-asiapacific.com
Biomedical Research and Support Services Pte Ltd
™
BRASS
STERILIZATION ASSURANCE
Our laboratory offers testing, knowledge and support in Sterilization Process Validation studies in conformance with Pharmacopoeia, ISO, AAMI and other international standards.
•
Ethylene Oxide (EO) Sterilization
•
Radiation Sterilization
•
Steam Sterilization
STERILIZATION ASSURANCE
RADIATION STERILIZATION Our ISO11137 Certificate of Compliance summarizes your quarterly Radiation Sterilization bioburden evaluation and dose verification data to support your audit programmes. • • • • •
Bioburden Validation 3-Lot Bioburden Analysis Dose Verification Sterilization Dose Establishment Quarterly Dose Audit
ETHYLENE OXIDE AND STEAM STERILIZATION Installation Qualification (IQ) and Operational Qualification (OQ) of Chamber BRASS™ shall gather objective evidence to ensure that the sterilization chamber has been installed correctly through installation qualification (IQ) and challenge the process parameters to assure that the sterilization chamber meets all defined requirements under all anticipated conditions of sterilization through operational qualification (OQ). Copies of the chamber supplier qualification studies should be used as guides, to obtain basic data, and to supplement the IQ study. During the OQ study, process parameters shall be measured in order to maintain a state of control.
PHYSICAL PERFORMANCE QUALIFICATION BRASS shall gather objective evidence to demonstrate that the sterilization process will consistently produce acceptable results under normal operating conditions. The time, temperature, humidity, pressure and sterilant concentration parameters shall be determined.
Microbiological Performance Qualification METHOD A: SURVIVOR CURVE CONSTRUCTION The lethality of the sterilization cycle shall be determined by construction of a survivor curve using direct enumeration of survivors. METHOD B: FRACTION NEGATIVE METHOD The exposure time required to achieve a specified probability of the survival of the test organism shall be calculated from the D-value. METHOD C: HALF-CYCLE METHOD The minimum exposure time required at which there are no survivors is achieved. The routine cycle should be twice the exposure time.
Method
TABLE 1: Variations in Information Obtained from Different Sterilization Validation Methods
A
B
C
Cycle Development
YES
YES
YES
Sterility Assurance Level (SAL)
YES
YES
NO
D-value
YES
YES
NO
Overkill
YES
YES
YES
® E-mail: enquiries@brass-asiapacific.com Website: http://www.brass-asiapacific.com
Biomedical Research and Support Services Pte Ltd
