Location: Boston, Massachusetts

Join us at the American Chemistry Society National Meeting & Expo this August. Our Technical Services team will be discussing cleaning validation methodologies, approaches, and applications throughout the ANYL: Methodologies for Use in Cleaning Validations session track on Thursday, August 23rd. This session will include the following four presentations. 

Date: Thursday, August 23rd 
Time: 1:30 PM - 4:35 PM 
Room: 153A, Boston Convention & Exhibition Center 
Full Agenda & Session Details Here

ANYL 529: Choosing Appropriate Analytical Methodologies for Use in Cleaning Validations
Date & Time: Thursday, 8/23 at 1:40PM 
Presented by: Herbert Kaiser & Bruce Ritts 
Room: 153A 

Cleaning validations are very difficult and time-consuming processes to perform. They can be made easier if an appropriate method for analyzing the residual soil is used. The method used should be based on the previously established residue limits of the active and cleaning agents and techniques available to the lab performing the study. It is important to understand what is left on a surface and what comes off a surface during and after cleaning. The residues left behind could either be organic or inorganic materials. There are many choices of analytical techniques that can potentially be used to quantitate these residues. An important question is: Which One? This talk will address this question and describe various analytical technologies available for use and their applications, particularly for cleaning agent residues.

ANYL 530: Rethinking Cleaning Validation for Active Pharmaceutical Ingredient Manufacturing 
Date & Time: Thursday, 8/23 at 2:25PM
Presented by: Dijana Hadziselimovic 
Room: 153A 

Cleaning validation is a regulatory requirement around the world and an integral process step within the manufacturing of active pharmaceutical ingredients (API), pharmaceuticals and biopharmaceutical products. Manufacturers strive to improve the efficiency, cost, quality, and time required to design, qualify, and monitor the cleaning process. The approach of designing, qualifying, and monitoring a process, such as cleaning is labeled a life cycle approach. This presentation focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance. 

ANYL 531: Effective Cleaning Validation of Reusable Medical Devices
Date & Time: Thursday, 8/23 at 3:10PM
Presented by: Amy Thanavaro 
Room: 153A 

Reusable medical devices come in different shapes, sizes, and complexities and are composed of many different materials. The challenge for manufacturers is to validate a cleaning process to ensure that the devices are free of residues. Residue detection methods for cleaning validation can involve the choice of specific methods for individual components from soil ingredients or it can involve non-specific methods that detect the presence of a blend of soil and cleaning agent ingredients, such as total organic carbon and conductivity. Establishment of the cleanliness limits and identification of the challenge conditions are also assessed and established prior to the process validation. The choice of analytical methods and sampling challenge will be discussed.

ANYL 532:  Evaluating Surface Cleanliness Using Risk-based Approach
Date & Time: Thursday, 8/23 at 3:40PM 
Presented by: Paul Lopolito 
Room: 153A 

Regulated companies that use automated cleaning applications have always struggled with correlating rinse sample quality or visual inspection to surface cleanliness. The process typically involves performing 100% spray coverage testing, rinse recovery testing, specific or non-specific analytical method qualification, surface sampling and recovery testing of the sampling technique and visual inspection performed during the cleaning validation. Each element of the justification needs to be reviewed and evaluated during the cleaning process design stage to defend a lean approach in continuously monitoring the cleaning process. A risk-based approach, supplemented with laboratory studies and information from published literature can be leveraged in the justification to reduce testing during cleaning qualification and continuous monitoring stages without impacting quality. This approach has helped correlate rinse sample quality or visual inspection and justify a lean approach to continuously monitoring surface cleanliness.

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