Sterile Filling is the critical stage of any biopharmaceutical product.
This seminar is here is to present both new technologies for filling but also sterile filling in isolators, small scale filling, ready to fill containers, single use filling equipment and how to set up extractable and leachable studies.
Small scale filling equipment will be displayed with expert vendors ready to demonstrate and answer questions.
The vendors that will be attending are from:
Merck Millipore (single use technologies), MAR (small scale filling), Ompi (ready to fill containers), ToxiKon (experts on extractables).
Anyone attending the seminar will be able to address the following questions:
- What are the equipment selection options for sterile filling
- How to solve typical problems for sterile filling
- What single use filling equipment is available for sterile filling
- How to combine filling and isolators
- What specialized equipment is suitable for small scale filling
- How can I learn from the experience of others in detailed case studies
Seminar program:
| Duration |
Topic |
Speaker |
08:30-09:00
|
Registration |
| 09:00-09:15 |
Introduction
|
Shlomo Sackstein
CEO Biopuremax |
| 09:15-10:00 |
Ready to fill glass containers for sensitive drugs, Glass Containers and analytical services needed for choosing the right drug configuration
|
Odra Pinato
SG Lab Analytics Coordinator, Ompi |
| 10:00-10:45 |
New technologies in Aseptic Filling
|
Sarel Chen Tov
CEO, Biopharmax
|
| 10:45-11:15 |
Coffee Break - Vendor Demonstrations |
| 11:15-12:00 |
Small scale filling
|
Simona Berretta
Sales Area Manager, M.A.R. Spa
|
| 12:00-12:45 |
Single-Use Technology in Final Fill: process design and quality considerations |
Dr. Simone Biel
Field Marketing Single Use Technology
EU Process Solutions,
Merck Millipore |
| 12:45-13:45 |
Lunch - Vendor Demonstrations |
| 13:45-14:30 |
Case study – New aseptic fill finish pilot facility for Teva branded sterile pipeline
|
Arnan Ben David
Director - Global Sterile Engineering, Teva
|
| 14:30-15:15 |
Coffee Break - Vendor Demonstrations |
| 15:15-16:00 |
How to Set-up Extractable & Leachable Studies for Small Volume Parenteral Applications (Vials, Syringes and Cartridges) |
Dr. Dries Cardoen
Study director/Project manager Extractables and Leachables,Toxikon
|
| 16:00-16:30 |
Panel
All speakers & special guest participant: Rachel Shimonovitz, Head of Inspectorate, GMP, Israeli Ministry of Health
|
Note: the program and speakers are tentative and subject to change without prior notice.
Target Audience:
This Seminar is a perfect learning session for:
- Engineering and Project managers wanting to learn relevant methods in the field
- Production personnel dealing with sterile filling
- Procurement and maintenance persons wanting to understand more
- Quality responsible persons who need implementation data
- Validation managers and engineers
- Operations and logistics personnel
Participation Fees:
PDA members - 650 NIS
Non members - 850 NIS
 |
Parking:
Parking will be available at Kikar Atarim parking area, 165 Hayarkon st. Tel Aviv
Parking coupon (40 NIS) will be available at the hotel concierge. |
|
