Both pharmaceutical and biotechnology utilizes wet production systems.

The systems that need to be made sterile and then kept sterile or aseptic, and then these systems perform complicated production processes.

In this course the basics and advanced points for design of sterile and aseptic systems are set out in an orderly and well organized way.

Benefits to the Participants

·         Learn the engineering aspects, configurations and requirements relating to aseptic   and sterile production.

·         Get acquainted with guidelines and regulatory expectations will be presented as well as methods and approaches to this critical topic.

·         The total spectrum of processing will be discussed: Definitions, Methodology, Physical containment, Production Environment, Production Equipment, Support systems.

Issues to be covered

1. Aseptic and Sterile: Definitions
2. Documentation and Methodology: BOD, URS, PFD, P&ID, Layout
3. Physical containment: Biohazards, potent and cytotoxic products
4. Production Environment: Clean room background
5. Production Equipment: Bioreactors, UF, tanks, pumps, valves
6. Support systems: SIP, CIP, SW, PW, WFI, CA, Biokill;
7. Sterilization: moist heat, dry heat, gases & fumigants, radiation
8. Product & Raw Material transfer & Connections: liquids and solids
9. Drains and waste: removal of undesirables from process
10. Control: Instruments, algorithms, software, hardware

Who should attend

• Production personnel and engineering that have a prior basic experience in production methods
• QA and RA personnel involved in installing, maintaining, reviewing and qualifying systems

About the Speaker

Shlomo Sackstein: is the VP for process and validation at Biopharmax from the S&A group. Biopharmax designs, installs, commissions and validatesTK plants for the Pharma and bio-Pharma industries.

Shlomo served as engineering department head in S&A for over 10 years and has been the VP for five. During this period he has installed hundreds of aseptic and sterile production facilities globally.

Shlomo's specialty is aseptic processing and related utilities with an emphasis on efficient and robust design with sophisticated controls and instruments.