Cleanroom Injection Molding

1. Cleanroom Injection Molding

2. Cleanroom Injection Molding What is a Cleanroom? A cleanroom is an enclosed clean area often used for manufacturing, testing and research applications. Cleanrooms are designed to remove airborne contamination that could have an adverse effect on the process or product. Commonly cleanrooms are used to control environmental conditions, factors such as air temperature and humidity are maintained at a constant value. Often these areas are validated and monitored to ensure that the internal environmental conditions remain within the specified limits. Predominantly used by the pharmaceutical, healthcare and life sciences industry’s, cleanrooms provide a clean and stable environment for the production of plastic components.

3. Cleanroom Injection Molding Cleanroom classifications Analysis of the risk of contamination: article class, number of process steps, etc. Risk = (severity of consequences + probability of occurrence) / probability of detection ISO classes include the particle count GMP classes include the particle count and the germ count

4. Unidirectional Room Nonunidirectional Room HEPA HEPA HEPA HEPA HEPA HEPA HEPA Cleanroom Injection MoldingHow do they work? Cleanrooms use filters to remove airborne contamination. High-efficiency particulate air (HEPA) filters are used to remove airborne particles as small as 0.3 microns. For increased levels of cleanliness, Ultra Low Particulate Air (ULPA) filters are required. There are two main types of cleanroom design, unidirectional and non-unidirectional, essentially they are both designed to circulate air movement and direct particulates towards the vents for filtration. Generally, ventilation is close to the ground level. Air circulates through the vents and the filtered air returns to the top of the cleanroom before beginning the cycle once again. Temperature and humidity are often controlled within this process.

5. higher cleanroom class low class cleanroom Δp Δp Δp Cleanroom Injection Molding Basic Design Philosophy for Cleanroom Layouts outdoor secondary areas personnel flow pressure drop from clean areas high class cleanroom core area finished goods flow material flow waste Source: Fraunhofer Institut

6. Cleanroom Injection Molding Cleanroom Design

7. Cleanroom Injection Molding Working inside a cleanroom Working inside a cleanroom naturally increases contamination, therefore depending on the cleanroom classification, specialised clothing is usually required. Most cleanrooms will have an intermediate changing area before entry, these are divided by airtight doors. Protective clothing must perform a dual function. Firstly, it should be designed as not to emit particulate contamination into the surrounding environment. Secondly, it should be designed to contain any contamination produced by the human body. This can include human hair, skin, and particulate contamination form a persons clothing. Clothing often required in cleanrooms: • Overall • Hair net • Face mask • Gloves • Shoes • Beard cover

8. Cleanroom Injection Molding Some perspective on size

9. Cleanroom Injection Molding Testing and validation Flow analysis are performed within cleanrooms to review the air flow. During testing and validation activities, a fine mist is used to simulate how the particles within the air will move. Particulate analysis is carried out on each process to establish the extent of contamination and validate if this is within the specified limit. Thermal analysis allow an understanding of the limit of thermal position from the equipment within the cleanroom. Material analysis stations are used to monitor the level od contamination that has settled on surfaces within the cleanroom. Particle analysis Thermal analysis Material analysis Flow analysis

10. Cleanroom Injection MoldingEngel technology to aid cleanroom manufacturing Cleanroom feature: Barrel exhaust During the molding process, purging introduces the highest amount of contamination. It‘s estimated that maximum particle value can exceed the acceptance limit by a factor over 100 during purging on a standard machine. ( 0,5µm particle per m3 over time in min. – with TPE purge duration 30 seconds – measurement sensitivity to 60 Mio. Measurement in ENGEL Cleanroom ISO 7)

11. Cleanroom Injection MoldingEngel technology to aid cleanroom manufacturing Positive effect of the exhaust feature: reduction of the heat load The surface temperature of the barrel enclosure is reduced to less than 45°C The standard barrel is the largest heat source of the machine

12. Cleanroom Injection MoldingEngel technology to aid cleanroom manufacturing Hygienic design: encapsulated bearings for a clean toggle Clean toggle for a clean environment Closed-loop-lubrication reduces inner friction, oil consumption and undefined lubrication states

13. Cleanroom Injection Molding Cleanroom Qualification Cleanroom features for product protection and ease of cleaning Machine outside a controlled environment needs HEPA filters Encapsulated conveyor belts need to combine protection to the outside with max acessibility for cleaning Care for the details and reduce abrasion

14. Cleanroom Injection MoldingEngel technology to aid cleanroom manufacturing ENGEL viper is qualified for GMP C and ISO 7 cleanrooms Machine integrated ENGEL viper robot series is certified for cleanroom operation

15. Cleanroom Injection MoldingEngel technology to aid cleanroom manufacturing FDA approved materials Certificates for materials in touch with the molded products- Belts of conveyors - EOAT suction cups and gripper - Automation part fixtures FDA approved grease FDA approved hydraulic oil