Thursday September 19, 2019
12:00 Noon – 1:30 pm EDT
Instructor: Richard Forsyth
This Web Seminar will present a detailed overview of best practices for cleaning validation swab recovery and sampling for Active Pharmaceutical Ingredients (APIs) and detergents from product contact surfaces of equipment in the pharmaceutical industry. All aspects of swab sampling will be discussed with the emphasis on how swab sampling ties into the cleaning validation program.
Current regulatory expectations and how they impact swab recovery and sampling will be reviewed. Of note will be the expectations for acceptable recovery studies and concerns for instances of low recoveries.
The swab parameter phase evaluates the parameters necessary to clearly demonstrate that a swab sampling will accurately and consistently provide data that demonstrates a cleaning validation study is successful. The swab parameters are evaluated individually to assess their impact on swab data. The calculated cleaning limit directly impacts the swab parameters to be validated.
- Coupon material of construction (MOC)
- Residue spike level
- Number of spike levels and replicates
- Recovery factor determination
- Swab area
- Type of Swab
- Number of swabs
- Swab solvent
- Swab technique
- Personnel
- Sample container
- Sample Stability (Pre- and Post-Extraction)
- Extraction solvent
- Extraction method
- Extraction time
- Test method
- Sample Locations
- Recovery execution example
Each parameter of swab recovery will be reviewed for different approaches and optimal parameters are proposed and contrasted to less defendable choices.
The swab method development phase takes the swab parameters and develops a swab method based on the physical properties of the API or detergent, the interdependencies of the swab parameters, and the sensitivity required by the cleaning limit. Swab method development optimizes the Swab parameters to a level that assures successful recovery and consistent swabbing over time.
The swab recovery validation phase will provide documented evidence through an executed protocol which provides a high degree of assurance that the swab sample consistently removes API and detergent residues to demonstrate levels below the pre-determined acceptable levels to provide ongoing assurance that swab sampling remains in a state of control.
Swab recovery and sampling pitfalls are reviewed to point out potential issues to avoid them rather than fall victim to simple errors. Pitfalls reviewed go beyond the swabbing to include quality systems and other facility and documentation issues.
Teaching objectives for this presentation include:
- Regulations
- Validation Parameters
- Swab recoveries and techniques
- Designing the swab recovery
- Designing the swab recovery study
- Execution
- Transferring swab sampling.
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-143