Clean compounding | processing
The role of plastics in the medical device and pharmaceutical industries continues to expand and central to producing compounds capable of meeting the exacting standards required is the cleanroom, writes Mark Holmes
Keeping compounding clean
The role of every cleanroom in manufacturing industry is to control an environment by limiting the presence of sub-micron sized particles and modifying inadequate environmental conditions. Cleanrooms maintain low levels of pollutants such as dust, airborne microbes, aerosol particles and chemical vapours. Other environ- mental parameters, including temperature, humidity and pressure can also be controlled in these facilities. The cleanroom has become essential in the electronic, high-tech, semiconductor and aerospace industries, as well as for medical device technologies and in the pharmaceutical sector where clean, safe and contami- nant-free products are imperative to the ability to manufacture and deliver a viable product.
Cleanroom essentials As the versatility and performance of plastics has increased, their role in the medical device and pharma- ceutical industries has grown – expanding the need for plastics compounding in cleanroom conditions to meet these stringent requirements. According to Dr. Philip R Austin, Chief Executive Offi cer of Acorn Industries - a provider of cleanroom solutions to manufacturing industry - and author of The Encyclopaedia of Cleanroom, Bio-Cleanroom and Aseptic Areas, one of the main developments in clean compounding at present is the widespread adoption of laminar fl ow cleanroom designs and the application of current cleanroom operating information that has been used in other industries.
www.compoundingworld.com When planning a cleanroom plastics compounding
facility, Dr. Austin recommends that it is most important that the entire operation be contained in at least a Class 1000 Cleanroom that complies with US Federal Standard 209 or the equivalent Class 6 Cleanroom as defi ned in ISO 14644-1. “The actual operating equipment should be under
Vertical Laminar Flow Class 100 Cleanroom conditions per Fed. Std. 209 or the equivalent Class 5 Cleanroom per ISO 14644-1,” he says. “In addition, specialised air fl ow nozzles providing a Class 10 clean air conditions per Fed. Std. 209 or the equivalent Class 5 Cleanroom per ISO 14644-1 need to be installed and directed at the output of any extrusion machines. The cleanroom must have the proper change room, air locks and other design features suitable to its cleanliness levels.” In addition, before any equipment is installed the
cleanroom construction must be fully completed and tested. “The room must be tested to ensure that it meets the design cleanliness levels specifi ed in the construc- tion documents. This certifi cation should be provided by an independent Cleanroom Testing Group using automatic light scattering particle counters,” he says. There are a number of key requirements and
operational essentials for a cleanroom compounding extruder, according to Austin. “It must be possible to disassemble critical components of the extruder for precision cleaning and there needs to be dedicated ultrasonic cleaning equipment available to do this,” he
April 2016 | COMPOUNDING WORLD 15
Main image: A clean
compounding line installed at Foster
Corporation
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