ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA ISOLATORS and EQUIPMENT INTEGRATION Loris Rinaldi Learning Objectives • At the conclusion of this session, participants will be able to: • Evaluate overall isolator performance. • Recognize key aspects for equipment integration into isolators. • Address containment and cleanability requirements for isolators. 2 1
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA Containment • Using an accurate pressure control, the system must •The internal pressure must be guarantee an internal lower than the external pressure pressure lower than the external pressure ∆ p = 50 ÷ 250 pascals • In case of accident (leak, glove leaks…) the system must be able to maintain an inward air flow, in order to avoid the exit of any toxic product (powder, liquid or gaseous) 3 Aseptic • Using an accurate pressure control the system must guarantee an internal •The internal pressure must be pressure higher than the higher than the external pressure external pressure ∆ p = 50 ÷ 250 pascals • In case of accident (leak, glove leaks…) the system must be able to maintain an outward air flow, in order to avoid any contamination of the internal environment by non aseptic air 4 2
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA O 2 and Moisture control • Some products are sensitive to N any contact with O 2 and/or moisture. In those cases the system must be purged with The internal environment must be O2 and Moisture free Nitrogen or other inert gases and it must be equipped with sensors to evaluate the environment before that any activity starts. • With high sensitive products the system must be equipped with a purification system in order to reach very low levels of O 2 and moisture (few ppm) 5 Isolators for all types of applications • Three main aspects to consider: 1) Environmental control 2) Equipment integration 3) Cleanability 6 3
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 1) Environmental Control - ISO 10648-2 leak tightness classes 1-4 - OEL/OEB - Air Flows 7 ISO 10648-2 leak tightness classes 1-4 Any Isolator should pass the Leak Test class 2 ISO 10648-2 !!! 8 4
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA OEL/OEB OEL OEL Range Design 1 > 1000 µg/m3 General room ventilation. Conventional open equipment with local exhaust ventilation (LEV) 2 50 to 1000 µg/m3 Semi-closed to closed material transfers; laminar flow / top-down flow, engineered LEV. 3 20 to 50 µg/m3 Transfers using direct coupling & closed systems, selected use of unidirectional air flow booths. 4 1 to 20 µg/m3 Totally enclosed processes; transfers using direct coupling; barrier/isolator technology. 5 < 1 µg/m3 Isolator technology; remote operations, fully automated. 9 Unidirectional Air Flows Air inlet • 0.45 m/s � 20% air HEPA Filter speed (1.48 ft/s � 20%) • Fastest “ambient class” recovery time • Excellent with powder Air inlet (in that case a top- HEPA Filter down flow must be adopted HEPA Filter Air outlet • The huge amount of air to be handled must HEPA Filter be taken into consideration Side views Water Drain 10 5
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA Turbulent Air Flows • More than 20 air changes per Air inlet Air outlet hour • Higher “ambient class” HEPA HEPA recovery time than with the Filter Filter 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 Front view • Some areas can remain dirty (non reached by the air flow) 11 Air flows evaluation • Turbulent flow Isolator volume X number of air changes/hour 2 m 3 x 20 air changes/ hour = 40 m 3 /hour 70.63 Cu ft x 20 air changes/ hour = 1,412 Cu ft /hour • Unidirectional flow (area covered by the flow) x (air speed) x (3600 number of seconds in a hour) 2 m 2 x 0.45 m/s x 3600s = 3,240 m 3 /hour 21.52 Sq ft x 1.48 ft/s x 3600s = 114,658 Cu ft/hour 12 6
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 2) Equipment Integration - Mechanical Integration - Cables/Electrical connections - Gaskets/Seals - Technical Area 13 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. 14 7
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 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 15 Mechanical Integration 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!! 16 8
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA Mechanical Integration 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!! 17 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 18 9
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA Mechanical Integration Over all process, not only mechanical but SW, One PLC and one HMI, I/O Exchange, Safety Interlocks, all the way to the stairs sheeting… 19 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 (316L, with different gaskets from NBR to PTFE) All connections are a potential source of Leakage. High quality components should be a must!!! 20 10
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA Gaskets/Seals • Static Gaskets Vs Pneumatic Gaskets • EPDM Vs Silicon • Custom Design Vs Standard Cleanability and Leak tightness are critically dependant on the gaskets!! 21 3) Cleanability - Surfaces: Isolator Design and Manufacturing - Valves and Piping - Suitable Equipment for WIP - Empirical tests for WIP Mock-up 22 11
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA 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. 23 www.comecer.com Water Distribution System • VALVES: Membrane/Diaphragm Valves VS. Butterly or Ball type • PIPING: Stainless Steel With Full Pentration Weldings VS. Plastic piping All components should be suitable also for aseptic applications Avoid potential bacteria growth in the water 24 distribution system!! 12
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA Draining System • Sanitary Valve VS. Butterfly/Ball Type • Slope: Correct inclination >1% 25 Empirical tests for WIP Mock-up 26 13
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA WIP Vs. CIP • The isolators can be dryed using hot Capillary Effect to be air(supplyed by a dedicated HVAC) considered, increases • All circuits are self-drained evaporation time, ex.: • CIP? Fully automated recipes screws, rivets... 27 (washing + drying) Summary • Efficient approach to Isolator project requires particular attention to: • Correct integration of equipment into Isolators to ensure optimal containment. • Right choice of connection components, mechanical interfaces and gaskets to minimize the risk of leaks. • WIP distribution systems details and components, to ensure optimal drainage and cleanability and avoid cross contamination and bacteria growth. 28 14
ISPE Tampa Conference 22-25 February 2010 Tampa, Florida USA Thank You! Loris Rinaldi, Sales Manager Americas COMECER 429 Lenox Ave Miami FL 33139 (305) 606-6020 Lrinaldi@comecer.com 15
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