- Environmental control
- Equipment integration
- Cleanability
Environmental Control
- ISO 10648-2 leak tightness classes 1-4
- OEL / OEB
- Air Flows
ISO 10648-2 leak tightness classes 1-4
OEL / OEB
Unidirectional Air Flows
- 0.45 m/s ± 20°/o air speed (1.48 ft/s ±20°/o)
- Fastest "ambient class" recovery time
- Excellent with powder (in that case a top-down flow must be adopted
- The huge amount of air to be handled must be taken into consideration
Turbulent Air Flows
- More than 20 air changes per hour
- Higher “ambient class” recovery time than with the Unidirectional Flow, due to the lowest volume of air used
- Excellent for transportable or small size Isolators
- Excellent when an inert gas (Nitrogen, Argon…) must be used in alternative to the normal Air
- Some areas can remain dirty (non reached by the air flow)
Equipment Integration
- Mechanical Integration
- Cables/Electrical connections
- Gaskets/Seals
- Technical Area
Mechanical Integration
- Different degrees of complexity : attention to all details!!
- Removable platforms.
- Rapid connectors for liquids.
- Electrical connectors for high vacuum applications.
- Remote electrical & control panels.
Mechanical Integration
Main Equipment
Ex. Micronizator (Jet-Mill) : high dusts residuals and electrical sparks
- Closed environment with Nitrogen Atmosphere
- All electrical motors placed externally
- Completely Washable System
Utility Type
- Gas, Liquid
- Electrical, Pneumatic
- Temperature, Pressure
- Aggressive Liquids
- Solvents/Acids
Suitable Materials
- PTFE, PVDF or Stainless Steel
- Ergonomics and space constraints require advanced design studies !!
Mechanical Interfaces
- Flange interface (Very important ! ) The equipment is ready to be integrated into an isolator?
- The equipment manufacturer has to guarantee that the equipment is leak tight !
- The overall leak tightness should not be compromised!
Tests, LBM, Integration Expertise !
Mechanical Integration : Retrofit
- Working plane retrofit
- Electrical panel retrofit
- Lower Mechanical area retrofit
- Check all crevices, and connections from upper working plane to lower technical area, mechanical connections: Sealed? Washable?
No passage of material from top to down: Pressurize Lower Mechanical Area
Mechanical Integration
O ver all process, not only mechanical but SW , O ne PL C and one HMI, I/ O Exchange, Safety Interlock s, all the way to the stairs sheeting…
Cables/Electrical connection
- Electrical Connector for vacuum applications avoid passage of air (Ex. Fisher, Douglas EC , type of connection)
- Rapid connectors for liquids such as Staubli (316 L , with different gaskets from NBR to PTFE)
- All connections are a potential source of Leak age.
- High quality components should be a must !
Gaskets/Seals
- Static Gaskets Vs Pneumatic Gaskets
- EPDM Vs Silicon
- Custom Design Vs Standard
Cleanability and Leak tightness are critically dependant on the gaskets!!
Cleanability
- Surfaces: Isolator Design and Manufacturing
- Valves and Piping
- Suitable Equipment for WIP
- Empirical tests for WIP Mock - up
Surfaces: Isolator Design and Mfg.
- All of the internal angles should have a radius of curvature of 20mm to facilitate the cleaning and sterilization operations.
- All welds are ground, smoothed, and polished.
- All stainless steel components, welded using TIG method.
