š¢ Please note this event is IN-PERSON. All registrations subject to availability and approval by the host sponsor. Confirmations will be sent prior to the workshop.
Registration deadline: 23 Oct 2023
Cleaning Considerations for Lipid Nanoparticles and Therapeutic ProteinsĀ
- Understand the complexity of lipid nanoparticle (LNP) delivery vehicles
- Review solubility and cleaning concerns with LNPs and therapeutic proteins
- Use of a laboratory model to develop an effective cleaning procedure for LNPs and therapeutic proteins
- Case study for technical transfer to cleaning validation of manufacturing equipment
Presenters: Paul Lopolito and Richard Chai
Navigating Annex 1: Cleaning of Product Contact EquipmentĀ
- Importance of cleaning life cycle approach.
- Understand the importance of having a good and complete User Requirement Specification(URS), so that the equipment manufacturer knows what the project scope is.
- Factory Acceptance Test (FAT) is also an important verification step to ensure that the unit was designed correctly (and according to the URS).
- Understand the importance of designing washer racks that match what needs to be cleaned. Customized racks may be required to improve loading efficacy and washing efficiency.
- Cleaning strategies to mitigate microbial and endotoxin/pyrogen risk
Presenters: Paul Lopolito and Nicholas Tan
Utilizing āHealth-Basedā LimitsĀ
- Guidelines
- Use of Default Limits
- Application of HBEL in Biotech
Presenter: Ravi Moorthy
Stainless Steel PreservationĀ
- What can go wrong with stainless steel surfaces?
- Risk-based approach to stainless-steel preservation
- Use of a predictive model to optimize stainless-steel preservation strategy
- Case study of stainless-steel preservation for operational excellence
Presenters: Paul Lopolito and Richard Chai
Speakers:
Paul Lopolito, Senior Technical Services manager, STERIS Corporation
Paul Lopolito is a Senior Technical Services manager for the Life Sciences Division of STERIS Corporation. He currently manages the Process and Cleaner Evaluation, PACEĀ® Program and provides global technical support related to process cleaning and contamination control, which includes field support, site audits, training presentations and educational seminars. Paul has over 20 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager. Paul is a frequent speaker at industry events including the PDA, ISPE, INTERPHEX, ACHEMA, AALAS, and IVT. Paul has published several articles and book-chapters related to cleaning and cleaning validation.
Richard Chai, Senior Technical Service Manager, STERIS Corporation
As a Senior Technical Service Manager with the Life Sciences Division of STERIS Corporation based in Singapore, Richard has been providing technical support and training to customers related to contamination control for cleanrooms and process equipment cleaning process. He is also a frequent industry speaker at industry events such as ISPE, and co-author of PDA book chapter. Richard has more than 20 years of pharmaceutical industry experience in manufacturing, validation, consultancy and technical support.
Ravi Moorthy, President, Quascenta
Ravi has 20 years hands-on experience in cleaning chemistry and cleaning validation. He has been instrumental in implementing detergent based cleaning and scientifically justifiable efficient cleaning validation programs at several companies world wide including Novartis, Pfizer, AbbVie and Teva. He was a pioneer in digitalising MACO limit calculations with the Residue application launched over 20 years ago, and eResidue being one of the first pharmaceutical applications to move to the cloud in 2014. Ā
Nicholas Tan, Regional Manager for Capital Equipment, STERIS Life Sciences
As Regional Manager for Capital Equipment in STERIS Life Sciences Division, Nicholas has been focused on growing markets in the APAC region since 2013. Prior to joining STERIS, he has a decade of experience in business development roles across the pharmaceutical, healthcare and medical device industries. His team has successfully implemented washing and sterilization projects in the APAC region. He is also a member of the ISPE EXCO Singapore Affiliate.