Location: San Diego, CaliforniaPDA Annual Meeting
- Defining manufacturing and quality requirements for immunotherapies, gene and cell therapy products
- Navigating the complexities of supply chain and serialization requirements
- Applying continuous manufacturing applications and flexible facility designs of the future
- Identifying new trends and potential disruptive developments in the health care sector
- Understanding rapid drug development pathways
- Defining and understanding risks and mitigation of those risks
- Interpreting the latest regulations and requirements of Data Integrity
- Establishing relevant control strategies through streamlining of parameter classification
Don’t miss this exclusive event! Stop by booth 201 to speak to our industry experts.
PDA Recognizes Jim Polarine
STERIS Senior Technical Service Manager, Jim Polarine, has been awarded the Michael S. Korczynski Award!
This award recognizes contributions made toward the development of PDA’s international activities, which is evident in Jim’s continual dedication to the growth of the program. Congratulations, Jim!
Don't Miss Our Poster Presentation
Contamination Control: Bringing Materials into the Cleanroom
Aaron Mertens, STERIS Technical Services Manager
Maintaining microbial control in the pharmaceutical cleanroom environment is not only a regulatory requirement and expectation, but is absolutely critical to prevent contamination of the finished drug product. Recently, expectations have evolved to include environmental monitoring of material handling airlocks. This trend places a need to evaluate material and equipment decontamination practices within the airlocks. Implementing an effective contamination control procedure in material handling airlocks significantly reduces the risk of microbial excursions in cleanrooms caused by transfer of contaminated materials through the airlock. Novel laboratory testing data demonstrates the advantage of implementing use of a sporicide in addition to alcohol application as best practice for decontamination of items entering the cleanroom through the material handling airlock. This presentation, based on a recent published chapter in PDA’s Contamination Control In Healthcare Product Manufacturing Volume #5, editor Jeanne Moldenhauer, provides recommendations for airlock and cleanroom practices, decontamination methods, decontamination chemistry selection, and material preparation with regards to contamination control and bringing materials into the cleanroom.
Key topics include:
- Best practice recommendations for contamination prevention and control
- Selecting a decontamination chemistry
- Equipment preparation
- Regulatory and GMP requirements
- Common questions, problems and cGMPs
Posters are displayed starting Tuesday morning and can be viewed in the Expo Hall at any time. Official break times when the poster is manned, is according to the schedule below:
- Tuesday: 10:00 AM - 10:45 AM
- Tuesday: 12:15 PM - 1:45 PM
- Tuesday: 3:15 PM - 4:00 PM
- Wednesday: 10:00 AM - 10:45 AM
- Wednesday: 12:15 PM - 1:45 PM