Outsourcing the precision cleaning, a solution for reducing the environmental impact Trade fair Hanover 2015 Heiko ZSCHIEDRICH Hanover April 15, 2015
Summary 1. Introduction and presentation of ECP 2. Objectives of precision cleaning 3. Characterization techniques at ECP 4. Conclusion: impacts of outsourcing precision cleaning
1. Introduction and presentation of ECP In-house precision cleaning Investment costs (cleaning equipments, purifying water systems, clean-room facilities) Outsourcing precision cleaning Focus on core business Semiconductor, pharmaceutical, medical, automotive, aeronautics, food business, high-tech industries in the watch field, metrology systems or gas applications.
Main industries being affected by particulate cleanliness Micrometric scale for comparison : Space, aeronautics Automotive injection Cage devices Electronic chip array Hair Orthopaedic prostheses socket prosthesis Ocular implant < 0,1 µm 75 µm 0 100 100 µm 200 200 µm 300 300 µm 400 400 µm 500 µm 5 µm
ECP s capabilities (1/2) ECP, subsidiary of Entegris Specialized in precision cleaning for cutting-edge industries 950 m² clean room class in Montpellier : Class 1000/ISO6/class B Class 1/ISO3 Different work flows in class100/iso 5/class A 2 DI water stations (5+4m 3 /h) for flexibility and back up Internal laboratory for measurement and characterization R&D department
ECP s capabilities (2/2) Parts of various sizes (from 1 to 800 mm) Different materials (plastics, metals, polymers, glass ) Know-how in particulate (down to 0,2 µm) and molecular decontamination Wet cleaning processes (sprays, ultrasonic, ), specific equipments Surface treatment (microblasting, passivation, trimming, cryogenics ) Assembling and packaging in our different clean room levels
Key figures of ECP + 150 active customers across Europe + 1.000 part references cleaned + 30.000 labels printed weekly + 1.000.000 parts cleaned per month Foup 450mm :760 x 610 x 790 mm screw: 1 mm x 2 mm. From the smallest part to the biggest
Quality management Our activity is ISO9001 and ISO13485 v2008 v2003 certified for particulate decontamination and ionic activity, micro-blasting, passivation, cryogenics, precision cleaning, assembly and packaging in clean room and pharmaceutical packaging solutions. ECP is also involved in an environmental approach ISO14001.
Business per activity sector Revenue based on the last 12 months
Sectors of activity Semiconductor Medical Pharmaceuttical Industry
Semiconductor Inspection control Pre-cleaning us + cryogenic Specific contamination Characterization Analysis Precision cleaning Product identification Plastic recycling Tracking Reuse loop Reclaimpak Maintenance
Sectors of activity Semiconductor Medical Pharmaceuttical Industry
Bone substitutes Medical Cervical cages Ocular implants conditioning devices Dental implants Elbow prostheses Lumbar cages Hip prostheses Various packaging Spine implants Knee prostheses Osteotomy plates
Sectors of activity Semiconductor Medical Pharmaceutical Industry
Pharma: Isolator Connectors Flanges Insertion and decontamination of the products Confinement enclosure Way out of the products ECP performs decontamination, drying and packaging in class B for isolator parts. Gloves
Pharma: Ultra clean apyrogenic bottles Ultra-cleaning and sterilization of glass bottles, individually packaged, with or without cap.
Pharma: Aseptic filling Filling of bottles with 5 to 250 ml with a peristaltic pump guaranteeing an aseptic mode (class A in B) Packaging of bottles of 250 ml to 5L (1000 l and 3000 l tank) Checking integrity of filter at sterilizing grade with "Palltronic Wipe pre-soaked Sealing of bags
Sectors of activity Semiconductor Medical Pharmaceutical Industry
Various industry Fluid handling Vacuum environment Machined parts Fittings, stainless steel valves, PVDF, PFA Rubber and plastic parts after injection Laser system Subset of vacuum equipment Particle accelerator EUV technology Cleaning before coating RGA analyzer
Various industry Automotive Aeronautical and space industry Engine propulsion plasma Sensor Connectors Joints, plastic fittings Machined parts Connectors, movable cores Valves
2. Objectives of precision cleaning Obtain clean products by decreasing the contamination level: Particles Micro-organisms (microbiology, endotoxins) Chemical residues Ensure a clean packaging of the products with packaging materials being able to keep the final cleaning and sterility state.
Parameters Measurement point Requirements for cleaning (1/2) Clean room according to the specific work class Ultra clean, deionized process water Water utilization E2 E1 SEL Specification ECP = purified water according to the European Pharmacopoeia Monitoring according to control plan DOC0006 Frequency of control Laborator y ECP Laboratory subcontract or SEL Processing technique Reverse osmosis - - - R : Back Conductivité at 20 C, 0,08 µs/cm or 12 MΩ D 1 / day - UV S Loop D : Start COT 500 ppb D 1 / day - Bacterial endotoxins Microbiological contamination 0,25 EU/ml 100 UFC/ml D - 1 / month R - 1 / month D - 1 / month R - 1 / month Nitrate (NO3 - and NO2 - ) 0,2 ppm D 1 / (3 month) - Aluminium 10 ppb D 1 / (3 month) - Heavy metals 0,1 ppm D 1 / (3 month) -
Requirements for cleaning (2/2) Decontamination equipments with wet cleaning techniques using or combining ultrasonic and spray methods Drying equipments using or combining blowing and steaming methods Packaging equipments for bag and blister applications followed by sealing of different packaging materials In-house laboratory for cleanliness control, analysis of the environmental parameters and the daily processes via different characterization techniques
Example of the different process steps Acceptance inspection Analysis of the parts to be cleaned Traceability Sandblasting Passivation Cryogenics Pre-cleaning Cleaning by ultrasonic technique and/or spray Decontamination Drying Final control Particles Characterization Drying equipment (under CL100 laminar workflow, by centrifuge ) Assembling Packaging Delivery Microbiological Analysis of contaminant traces Fe 45% Ca 28% Si 11% Na 6% Al 2% S 2% Mg 2% Cl 1%
Characterization techniques at ECP Granulometry, gravimetry, liquid particle counting (LPC) Microbiological control, bioburden test and endotoxin analysis Surfactant trace control Bag sealing validation Humidity Control Environmental Control Organic and ionic contamination SEM-EDX analysis Control of absence of a specific contaminant after the cleaning process (e.g. via ionic cromatography (IC)) Analysis of non-volatile residue, Residual Gas Analyzer (RGA)
4. Conclusion: Outsourcing precision cleaning leads to 1. Improved environmental compliance Water consump tion Waste water treatment Electric power consumption 2. Cost reduction and better focus on the core business Space for manufactu ring, R&D, Cleaning level + cleanliness analysis by specialists Running costs Cleaning equipment costs
Thanks for your attention! Any questions? ENTEGRIS CLEANING PROCESS 395, rue Louis Lépine 34000 Montpellier (FRANCE) Tel: +33(0)4 67 22 40 95 Fax: +33(0)4 67 22 49 90 E-mail: info@ecp-entegris.com www.ecp-entegris.com