Alexey Enenko

Head of validation group LAMSYSTEMS CC

Abstract:

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.