Biomaterials
The sterilisation of thermoplastics
Mitsubishi Chemical Advanced Materials’ (MCAM) LSG product portfolio and healthcare strategy continues to provide product solutions that protect medical devices and reduce healthcare associated infections. Eric Tech, healthcare strategic growth manager, explains what can be done.
he importance of sterilisation for class two medical thermoplastic devices has never been more important, given the fast response required to tackle the Covid-19 pandemic. Unforeseen factors including increased frequency of use and more aggressive chemicals used in sterilisation have challenged the health care industry to re-examine the overall effectiveness of sterilisation procedures. A clearer understanding of materials is needed from the perspectives of compliance and sterilisation to get products to market as quickly as possible. A strong driver impacting sterilisation technology in the healthcare environment is the systems management of healthcare associated infections (HAIs). It is estimated that approximately two million patients annually suffer from HAIs in the US, and nearly 90,000 are estimated to expire. The Centres for Disease Control and Prevention (CDC) has recently estimated the annual hospital costs of HAIs in the US are between $28bn and $45bn per year.
T
lock, manufactured under GMP, and are fully traceable making them candidates for both single use and multi-use class one and class two medical devices.
Meeting medical challenges Challenge one: Medical devices are increasingly more complex. No longer are medical devices made from one re-usable, autoclavable stainless steel material. Today’s devices are often made of dissimilar materials including thermoplastics, glass, and elastomer over mouldings.
Examples are many of today’s scopes or end of arm robotics that include electronics, sensors, and cameras that cannot be subject to traditional steam sterilisation at 134°C (273°F). Differences of coefficient thermal expansion among materials means they will expand and contract differently, potentially causing a seal or biological failure of the device. These products are best sterilised using a low temperature hydrogen peroxide (H2
O2 ) gas that does not expose the device to extreme
“Unforeseen factors including increased frequency of use and more aggressive chemicals used in sterilisation have challenged the health care industry to re-examine the overall effectiveness of sterilisation procedures.”
As the healthcare industry continues to demand more of engineering thermoplastics, Mitsubishi Chemical Advanced Materials (MCAM) continues to develop products to keep pace with the industry needs. The MCAM LSG portfolio are medical grade polymers preassessed for ISO 10993 biocompatibility and sterilisation. They also contain formulation
temperature swings and moisture. Solution: MCAM’s LSG stock shape portfolio provides a wide range of solutions to the most demanding medical device needs – offering consistency and precision when its most needed.
Some LSG stock shape products can be used both in steam autoclave and low
Medical Device Developments /
www.nsmedicaldevices.com
temperature hydrogen peroxide gas applications.
Challenge two: The increased aggressiveness of disinfectants to control HAIs continues to challenge engineering thermoplastics. This could be either a change in chemical composition or the time the disinfectant is left on a polymer. Most spray and wipe disinfectant instructions state that the product should be sprayed on, left on for one to five minutes, and then wiped off with a water- based solution. The wipe off stage is rarely followed, subjecting the thermoplastic to much longer durations of the chemical and could result in environmental stress cracking (ESCR) failure. Solution: MCAM’s fully stress relieved portfolio of LSG stock shape products offer improved ESCR resistance under extreme conditions and provides a reliable solution to the protection of medical devices from pre-mature failure and replacement. Parts machined from LSG shapes can be rigorously tested very quickly, providing confidence that a given polymer will meet both the ESCR and structural requirements of a given application. Before launching any new medical device, it’s important to consider the intended sterilisation protocols among the material performance criteria, which are set out during the design or redesign phase. Machining parts from shapes provides a fast and reliable means of making prototypes and even many production parts. MCAM’s LSG product portfolio and healthcare strategy continues to provide product solutions that both protect medical devices and reduce HAIs. ●
www.mcam.com/na-en/products/ meditechr-life-science-grade/life- science-grades
99
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116 |
Page 117 |
Page 118 |
Page 119 |
Page 120 |
Page 121 |
Page 122 |
Page 123 |
Page 124 |
Page 125 |
Page 126 |
Page 127 |
Page 128
