Need ISO Class 7/8 Cleanroom Injection Moulding?
9 May 2016
Class 7 Clean Room manufacturing cell for injection moulding and component assembly of non-sterile medical products.
Newly installed modular manufacturing cell operating at ISO Class 7/8
For customers requiring the assurance of cleanroom manufacture for components, we now, in addition to our white room, offer injection moulding in a fully validated EN14644 class 7 (10,000) cleanroom, staffed by fully trained operatives. Although this area is currently being used for predominantly medical component manufacture, it could be used for other sectors where a clean room environment is required.
Cleanroom Modular Cell for injection moulded components in thermoplastics
Tex Plastics Barnstaple specialises in the development and manufacture of mould tools, plastic injection moulded components and the assembly of complex devices. The modular cleanroom solution has been designed to meet the ever increasing demands of the company’s many customers within technically challenging medical, pharmaceutical and electronics market sectors.
Designing cleanroom production for injection moulding
Our factory is a clean environment, with extensive whiteroom manufacturing capability and was suited to most plastic injection moulding procedures. However, increasing demand for high-sensitivity moulded components, Tex Plastics’ Technical & Quality Director, Andy Clarke & Manufacturing Director Dave Kearney, set out to extend the proposition to provide cleanroom moulding operations within a Class 7/8 cleanroom.
Tex Plastics’ mission to develop higher performing, lower cost solutions for its clients, is complimented by a class 7/8 cleanroom system that includes automated clean-air canopies.
Overcoming the tooling challenge
Improving on today’s current available Clean Room facilities in the UK it was recognised in cleanroom production for an injection moulding process, the tool face is the most exposed area of the production line, so this is the area which requires the clean supply of air. The most effective way to provide this is to enclose the machine in a cleanroom, however this brings inevitable challenges when the tool needs changing.
Why a fully enclosed cleanroom wouldn't work
The most common solution is to build a large cleanroom that fully encloses the machine, mould and crane, which requires a large environment, in floor space and height as well as a negative impact on reducing carbon emission targets. This approach also cause’s increased opportunity for the risk of contamination and safety issues as the overhead crane inevitably retains particles and cleaning it is a cumbersome and difficult task - not to mention the hopper creating a mass of contamination within the cleanroom.
Modular was the way to go but it had to be the right solution
Whilst a modular cleanroom is a practical solution for many, TEX Plastics consider it creates unacceptable downtime as machinery requires an extensive full clean down following exposure to the external manufacturing environment. Increasing the risk of contamination and reducing the ability to offer a timely response to customer schedule changes.
The ultimate tooling solution: HEPA-lite™ automated canopies
Connect 2 Cleanrooms R&D team were set the challange and had the answer they installed a HEPA-lite™ canopy within its cleanrooms. Through a user-friendly touch screen interface, Tex Plastics are able to activate actuators that slide sealed HEPA-lite™ canopies back to allow overhead crane access to tooling.
Clean air is supplied at the critical point of production
This Tex Plastics driven requirement ensures that clean air is supplied at the critical point of production and reduces contamination by significantly limiting the areas of machinery that are exposed to the external environment during tooling changes. This limits downtime for cleaning, reduces risk of contamination and increases productivity.
Custom manufactured canopy
The canopy is a custom manufactured unit, containing a MAC10XL HEPA filter and is fully sealed to facilitate the re-circulation of the cleanroom’s air conditioning.
An LED warning beacon above the control panel visually indicates when the canopy is open, reminding operators to close the canopy, prior to new batch production.
This leading cleanroom, features LED strip lighting around the underside of the canopy for extra lux levels, illuminating the tool face for operators.
Auditable control if the cleanroom is operating out of specification
The touch screen interface also acts as a control system, allowing full control of HEPA filtration and lighting levels, as well as monitoring pressure levels and alerting staff if the cleanroom is operating out of specification.
All of the data is logged, exportable and auditable, to demonstrate performance and analyse production processes.
Effective cleanroom design with two Arburg injection moulding machines, packing area and goods transfer
There are 4 zones inside Tex Plastics’ cleanroom separated by partitions; two for Arburg injection moulding machines, a packing area and a goods transfer area. If one machine needs decommissioning or servicing, this can safely be done without affecting any of the other processes.
Flexible modular design can quickly expand cleanroom capacity
The modular design means that additional space can be added on to accommodate more machinery or create a larger packing area. This gives clients the peace of mind that scalability is achievable when required.
Tex Plastics supplied 3D models of their machines allowing Connect 2 Cleanrooms to maximise on floor space when designing its cleanroom.
Additional design features specified to maximise efficiency
- Open, Close, Kill control
- Sealed HEPA-lite™ unit can be opened for pre-filter access during validation
- Benches for the packing area supplied by Cleanroomshop.com
- Transfer area features a bench with goods in going over the bench and goods out under, plus a waste hatch to dispose of waste without leaving the classified clean area
- Injection moulding machines are part enclosed so the hopper is kept external to the clean environment as it is a high contamination producing component
Now fully operational and capacity already growing fast
The cleanroom is now fully operational, complimenting an already comprehensive “concept to completion” project solution for all conventional, white room and clean room thermoplastic requirements. Meticulous project management of comprehensive tooling validation protocols including Scientific Moulding disciplines ensures our customers know Tex Plastics assures technical capability and a competitive edge with a cleanroom production facility operating at maximum efficiency.