Contamination Control Considerations and Cleaning Challenges in Pharmaceutical Manufacturing
10 Jun 2019 | 9am-5pm | Genting Hotel Jurong, Singapore
Microbial / viral contamination and product cross-contamination are two of the major challenges faced by manufacturing companies within GMP regulated industries. Contamination will affect the drug product's safety, identity, strength, quality and purity. The adulterated drug product will pose significant risk to patient safety.
An effective preventive measure is to design an effective cleaning process, and also understand various causes of contamination and the strategies for remediation and preventive measures.
This seminar will include the following:
- Cleaning process design considerations
- Regulatory evolution on cleaning
- Critical cleaning parameters
- Type and selection of cleaning agent
- Lab scale study
- Health based acceptance limits
- Microbial contamination and remediation in water system / process equipment
- Sources of contamination
- Biofilm remediation
- Case study
- Strategies for remediation and prevention of rouge
- Understanding rouge formation
- Strategies for remediation and preventive measures
- Virus safety of cleaned surfaces
- Viral clearance strategy
- Understanding critical cleaning parameters and viral inactivation parameters
- Cleaning challenges and how to overcome them
Key TakeAways
Key take away from this seminar are the understanding of the regulations related to cleaning, important elements of cleaning process design, strategies of remediation of biofilm and rouge formation in water system / process equipment.
The common cleaning challenges encountered in GMP manufacturing are also discussed, including the strategies of remediation.
Speakers
Paul Lopolito,
Senior Technical Service Manager
Life Sciences, Formulated Chemistries
STERIS Corporation (read more)
Richard Chai,
Technical Service Manager
Life Sciences, Formulated Chemistries
STERIS Corporation (read more)
Agenda
|
08.30 - 09.00 am |
Registration |
|
09.00 - 10.15 am |
Cleaning Process Design Considerations |
|
10.15 - 10.45 am |
Tea Break |
|
10.45 - 12.00 pm |
Cleaning Process Design Considerations |
|
12.00 - 01.00 pm |
Lunch Break |
|
01.00 - 02.00 pm |
Microbial contamination and remediation in water system / process equipment |
|
02.00 - 03.00 pm |
Strategies for remediation and prevention of rouge |
|
03.00 - 03.30 pm |
Tea Break |
|
03.30 - 04.00 pm |
Virus safety of cleaned surfaces |
|
04.00 - 04.30 pm |
Cleaning challenges and how to overcome them |
|
04.30 - 05.00 pm |
Q&A |
Member: S$ 295* / S$ 355
Non-member: S$ 395* / S$ 455
*Early Bird rates valid for registrations before 10 May 2019