Effective Design, Validation and Routine Maintenance of Pharmaceutical Gases: 2-Day In-Person Seminar
Pharmaceutical gases such as Compressed, Nitrogen Argon gas systems used for the production of finished pharmaceutical or other types of products may either have direct or indirect impact to the finished products. These gases are also used for other medical and non-routine processes hence understanding the design, validation, routine monitoring, data management, failure investigations, regulations and applicability of each type of gas system ensures compliance to the required regulations. A detailed technical understanding of how to perform these critical steps during the initial evaluation or re-evaluation of a new, modified or existing gas system will eliminate expensive failure or remediation issues, inability to perform validation as well as routine testing and maintenance issues which ultimately impact or delay the release of the affected product.
This 2 days seminar will provide the attendee an extensive technical and practical knowledge that includes the step by step process of evaluating a new gas system through the design, installation, validation, routine monitoring/testing, data management, performing a gas failure investigation, excursion or out of specification results and trending so as to avoid the high cost associated with a poorly designed system. This seminar contains a lot of technical content, case studies, practical discussions and an exciting learning environment.
Why you should attend:
This seminar will provide an enormous amount of technical information and will be beneficial to those involved in the establishment, design, installation, validating, testing, review and approval of a new and modified or existing pharmaceutical gas programs so as to meet the requirements of ISO 8573, USP or FDA requirements. It will also benefit the vendors and suppliers of pharmaceutical gases to ensure compliance to the different regulatory bodies’ requirements.
Upon completion of this seminar, the attendees will be able to:
List the applicable regulations and how it applies to the different types of gases.
Plan, define, design, re-design, appropriately install, validate, routinely test and remediate a gas system to avoid future failure and to achieve compliance to regulations.
Define and design a robust Analytical and Microbiological testing program for pharmaceutical gases with each defined specific assay required for each type of gas system.
Design a robust pharmaceutical gas testing trending program and defining the alert and action levels for each test methodology to ensure a state of control for the gas systems.
Perform analytical and microbiological gas testing data review and management and utilizing the data for gas testing trend reports.
Perform Out-of-specification, Alert and Action Levels Excursion, Contamination or Failure Result investigation and Remediation of routine gas testing program.
Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM - 9:00 AM
Session Start: 9:00 AM
Regulations Guiding Pharmaceutical Gases
How to Choose a Specific Gas System
Argon Gas-Use and Applications
Compressed - Use and Applications
Nitrogen Gas - Use and Applications
Evaluating the Needs Prior to Choosing a Design
What to look for during this evaluation phase.
Needs versus Compliance Based Approach.
Understanding your product type.
Understanding your capabilities
Understanding your products or processes.
Understanding the impact to other operations and infrastructure.
Cost versus Benefits
Evaluating the Supplier or Vendor
Making the right choice
What to look for when choosing a pharmaceutical gas supplier or vendor.
Quality and Compliance, Customer Service or Both.
Supplier’s Role in the Evaluation Process
The Initial Design Planning Phase
Who to include when planning a pharmaceutical gas system
Impacted Operations and Processes
Involving the Impacted Department.
Involving the Quality Organization and Testing Operations
Seeking Feedback from Stakeholders
Weigh the Pros and Cons
Placing Ideas on Paper and Design Drawing
Comparing Design with other Possible Impacted or Related Systems
Choosing the Gas System Type and Design
Using ideas and decisions to design the gas system.
Verifying functionality/how to determine a good design
Compare design with validation plans
Compare gas design with current infrastructure to determine impact
Address all possible impact.
Involve Facilities and Engineering
Put design on paper and evaluate feasibility of design with the planned validation and routine testing
Validating Pharmaceutical Gases
Planning the Gas System Validation
Designing the Gas System Validation Protocol to meet regulations.
What to include in a robust pharmaceutical gas system validation protocol
Deciding on what use points, number of testing days and types of test to perform.
Setting the test specification or acceptance criteria (action levels)
Reviewing and approving the protocol.
Who should review and approve the validation protocol.
Validating Pharmaceutical Gases contd.
Designing a Pharmaceutical Gas System Report
What to include in the Pharmaceutical gas system validation report.
Data management of Pharmaceutical gas system validation result.
Translating the Pharmaceutical gas validation data into routine monitoring of the gases.
Handling out of specifications or deviations during the validation.
Approving the validation report.
Drafting Associated Standard Operating Procedures or Standard Test Methods
SOPs or STMs must be approved prior to routine monitoring and testing.
4:00pm – 5:00pm
Case Studies and Questions/Answers
Day Two (8:30 AM – 4:30 PM)
Routine Testing Programs for Pharmaceutical Gases
Designing a Routine Pharmaceutical Gas Testing Program
How to Transition from the Validation Phase into Routine Monitoring of Gases
Understanding what to include in the routine gas testing program
Types of pharmaceutical gas testing programs
Defining Pharmaceutical Gas Testing Frequencies and Specifications
Microbiological Monitoring and Testing Programs for Pharmaceutical Gases
Designing a Viable Airborne Testing Program for Pharmaceutical Gases
Performing the Sampling and Testing
Documenting the Results of Viable Airborne Particulate Testing
Interpreting the Results of Viable Airborne Particulate Testing
Designing a Non-viable Airborne Particulate Testing Program for Pharmaceutical Gases
Performing the Sampling and Testing
Documenting the Results of Non-viable Airborne Particulate Testing
Interpreting the Results of Non-viable Airborne Particulate Testing
Analytical Monitoring and Testing Program for Pharmaceutical Gases
Designing an effective Analytical Testing Program for Pharmaceutical Gases
Types of Testing to Include for Analytical Testing Program
Dew Point Evaluation
Considerations during the various types of testing
Best Practices to consider when testing pharmaceutical gases.
Appropriate gowning practices
Outlets and locations
Avoiding Common Mistakes
Pharmaceutical Gas Failure and Contamination
Types of Failures
Out-of-specification Investigation (Alert and Action Levels Excursions)
Types of Contaminants
Water or Vapor
Investigating a Pharmaceutical Gas Testing Failure or Contamination
How to initiate a pharmaceutical gas system failure investigation
What to include in a pharmaceutical gas system failure investigation
What to verify, evaluate and eliminate during the investigation
How to document the pharmaceutical gas system failure investigation
How to Disposition the Impacted Batch or Product Affected by pharmaceutical gas testing failure.
Common mistakes made during a pharmaceutical gas testing failure investigation
Remediation of Pharmaceutical Gas System Failures
Performing the remediation activities
Return to use processes and testing activities.
Routine Preventative Maintenance Programs
Effectively using test data derived from Pharmaceutical Gas Testing Program
Data management of Pharmaceutical Gas Testing Program
Trending of Pharmaceutical Gas Testing Data- Applying the Results
Routine Testing of Pharmaceutical Gas Systems –Post-validation Testing
Review of Case Studies- FDA Recent Form 483 Applicable to Pharmaceutical Gases
Case Study #1 – FDA Form 483 Associated with Pharmaceutical Gas Systems
Case Study #2 - FDA Form 483 Associated with Pharmaceutical Gas Systems
Case Study #3 - FDA Form 483 Associated with Pharmaceutical Gas Systems
How to Address Compliance Issues
Impact to Product/Batch
Impact to the Production Process
4:00pm – 5:00pm
Question and Answer Session