Alexey Enenko
Head of validation group LAMSYSTEMS CC
LAMSYSTEMS Approach to Isolator Development:
1) Positive-pressure and negative-pressure isolators. Operating principles. Pressure control and maintenance system.
2) “Laminar” and “turbulent” isolators. Configuration specifics.
3) Material transfer without impacting sterility. Two-door pass boxes. Pass box blow-down through the HEPA filter.
4) Leak-tightness of outer casing and inner chambers. Configuration specifics. Leak-tightness criteria. Control techniques.
5) Pneumatic sealing system for work opening.
6) Gloves and ports. Materials. Glove-integrity control system. Replacement procedure without impacting the leak-tightness.
7) Waste removal system.
8) Hydrogen peroxide disinfection systems: gas and spraying treatment. Fundamental differences. Configuration specifics.
9) Additional system and port equipment: technological gas and liquid supply, WIP (Washing-in-place) system.
10) Specifics of isolators for work with cytostatic materials.
11) Isolators with controlled inert environment.
12) URS (User Requirement Specification) approval.
13) Documentation issuance and FAT (Factory Acceptance Test) and SAT (On Site Acceptance Test) in accordance with GMP standards.
| Time and date | Venue | Topic | Speakers |
|
Thursday 25/11/2021 From 14:35 To 15:05
11/25/2021 14:35
11/25/2021 15:05
LAMSYSTEMS Isolation Technologies: Solutions and Upcoming Developments
Prezentation Zone B, Hall 8, Pavillion 2
|
Prezentation Zone B, Hall 8, Pavillion 2 |
"LAMSYSTEMS Isolation Technologies: Solutions and Upcoming Developments" |
Alexey Enenko |
Thursday 25/11/2021
From 14:35 To 15:05
Prezentation Zone B, Hall 8, Pavillion 2
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