processing | Clean compounding Fundamental elements of best practice
Achieving and maintaining cleanroom operating conditions is not an easy task. However, there are some simple rules that, if followed, can make the process easier, This checklist has been provided by cleanroom expert Dr. Philip R Austin, Chief Executive Officer of Acorn Industries. l Use good cleanroom garments. l Wear clean garments that meet ASTM F51 Class C cleanliness. l Wear protective garments properly, with all closures at neck and wrists secured. l Maintain an effective cleanroom janitorial programme. l Clean the extruders. l Make sure all HEPA filters in the air handling system are secure and not leaking. l Establish a cleanroom monitoring programme. l Train all personnel in cleanroom operation by non-company personnel. The Buddy training system is flawed. l Do not bring cardboard, paper or cellulous products into the cleanroom. l Vacuum the floor at least every other day.
throughout the supply chain in regard to raw materials and finished goods. However, cleaning procedures are obviously the most important elements to clean com- pounding. By following all the procedures, we reduce the chances of contamination and errors. We always say to our employees - if you see something, say something.”
Below: Hexpol TPE started up this new medical TPE line at its Elasto Sweden site last year
Capacity expansions Clariant recently announced expanded production capacities for Mevopur pre-coloured compounds for the medical industry at its ISO13485 sites in Singapore. Mevopur compounds and masterbatches are manufac- tured from pre-tested and batch controlled ingredients that have been biologically evaluated to ISO10993 and USP 87, 88 Class VI. They are compounded at three dedicated GMP ISO 13485’ certified production facilities including Lewiston, Maine, in the US, and Singapore as well as Europe The investment recognises that some customers
prefer to use a fully compounded resin, according to Steve Duckworth, Clariant’s Global Head, Healthcare Polymer Solutions. “A pre-coloured compound may be preferred over a natural/uncoloured resin plus concen-
trate because of technical difficulties with the moulding process or with more ‘difficult’ resins,” he says. “Clariant can give our customers both options with
the assurance that the raw materials, regulatory procedures and processing steps are all controlled in the same way. This allows, for example, a medical device company to validate both concentrate and compound, giving them the flexibility to choose later the route that best meets their processing, economic and technical requirements,” he adds. The investment extends the range of pre-coloured
Mevopur compounds compounded in the US to include melt-processable fluoropolymers, in addition to its existing slate of PP, PE, ABS, PC/ABS, PSU and PEEK. The Singapore facility can now offer PPS. Late last year, Hexpol TPE announced the start-up of a
new medical line and expansion of its technical centre at its Elasto Sweden operation at Åmål (the company claims it was the first European TPE compounder to gain ISO 13485 certification for development, manufacturing, marketing and sales of TPE compounds for medical devices). It will produce the company’s Mediprene grades. “High quality materials, produced under consistent
conditions with a strict raw material selection policy, all backed by specialist technical support, this is what we’ve built our medical strategy on,” says Niklas Ottosson, Medical Technical Manager at Elasto. “Our strong heritage in this sector gives us a deep understanding of medical device regulations and requirements, such as; traceability, reproducibility and formulation stability.”
Click on the links for more information: ❙
www.cleanroom-consulting-group.com (Acorn Ind) ❙
www.fostercomp.com ❙
www.plasticscolor.com ❙
www.clariant.com ❙
www.hexpoltpe.com
22 COMPOUNDING WORLD | April 2016
www.compoundingworld.com
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