18
THE HEALTH | AUGUST , 2021
| Innovation |
Cost savings for pharmaceuticals , medical devices players
Industries can now get their products tested locally and not abroad , thus saving costs and time
SIRIM Bhd has scored another first by introducing local testing services for the pharmaceutical and medical device industries . The testing services are carried out by SIRIM ’ s Industrial Biotechnology Research Centre ( IBRC ) and conform to new requirements by regulatory authorities in the last two years .
IBRC provides state-of-art facility for testing and offers an alternative for industries to get their products tested locally , rather than overseas , thus saving costs and time .
The new services are extractables and leachables ( E & L ) for pharmaceuticals and medical devices ; test for nitrosamines for pharmaceutical , medical devices and food as well as permeation , degradation and migration tests in gloves for medical use and food handling . Other tests include Polycyclic Aromatic Hydrocarbons ( PAHs ) and phthalates in gloves .
E & L testing enables manufacturers to identify , quantify , and identify the risk of leachable impurities migrating into a drug solution from container closure systems , processing equipment , packaging or medical devices .
IBRC general manager Dr Ahmad Hazri Ab Rashid said the new regulations and guidelines stemmed from the
Dr Ahmad Hazri
advancement in scientific knowledge on the effects of various compounds to human health and the lowest limits of analytical quantification of these compounds .
“ Companies are now looking at labs that can perform these tests . As far as we know , we are the only lab ( in Malaysia ) that is able to do the E & L test . For nitrosamines , the number of labs is limited as the equipment required to do the test is expensive . We ’ re one of the labs that is able to perform this test , while few labs offer permeation , degradation and migration tests in gloves ,” he said .
Serving international clients
Dr Ahmad Hazri added : “ We ’ re offering these services to industries so that they can meet the regulatory requirements , whether locally or globally . It ’ s a big advantage for the industries that they have a local lab ( SIRIM ) that can assist them in their submissions to the regulatory authorities in Malaysia and around the world .”
Besides serving top local pharmaceutical and glove companies , IBRC also serves international clients from Singapore , Thailand and New Zealand .
Permeation testing is designed to measure the breakthrough time for determination of the resistance of protective clothing , gloves , and footwear materials to permeation by potential hazardous liquid chemicals under the condition of continuous contact . By doing such testing , glove manufacturers can classify their glove performance level .
Degradation testing is designed for the determination of the resistance of protective glove materials to degradation by dangerous chemicals with continuous contact . This testing is mandatory for all gloves that offer chemical protection .
The classification of gloves according to its permeation characteristics will enable users to choose the right type of gloves for their specific applications to ensure the safety of the users .
Dr Ahmad Hazri said the rigorous testing procedures are important to these industries as a quality assurance that products from manufacturers meet the quality requirements of each product in the form of technical specifications .
“ The benefits of all these rigorous testing on these health products is the assurance that the product complies to the minimum quality standards and is safe for consumption and application .”
Wide range of services
SIRIM is establishing a Medical Device Innovation Centre ( MDIC ) with a mission of developing the nation ’ s medical device industry as a whole to enhance its competitiveness . MDIC aims to assist in building capabilities to address manufacturing gaps and market regulations as well as growing the product innovation capabilities of medical device manufacturers in the country .
SIRIM offers a wide range of services that include biomodelling and prototyping , industrial research and product innovation , technology commercialisation , accredited testing , certifications , training and consultation . Supported by its industrial research centres and subsidiaries , SIRIM has an extensive range of capabilities , from research and development to commercialisation , that industry players can tap into to facilitate market access .
To ensure the success of MDIC , all parties involved , such as the government , industry , and research institutes , have to work closely together . Essentially , the establishment of a solid platform will allow all industry players to move forward together for the benefit of both industry and the nation and ensure that nobody is left behind .
For organisations interested in obtaining IBRC services can visit www . sirim . my or call + 603-5544 6000 or e-mail web @ sirim . my to find out more . — The Health
Get a SIRIM certified face mask
BE CAREFUL when choosing a face mask during the current pandemic . If you obtain a substandard one , you may end up endangering your life and that of others by increasing the risk of infection .
But if you choose a face mask certified by SIRIM , you can be sure of its quality and high standards . The tests and inspections on the face masks are carried out by SIRIM QAS International , a whollyowned subsidiary of SIRIM Berhad , at its accredited and state-of-the-art testing laboratories in SIRIM Complex , Shah Alam .
SIRIM QAS notes that unlike the surgical masks used at hospitals which are regulated by the Medical Device Authority ( MDA ), face masks worn by the public are not regulated in the same manner .
Substandard face masks carry risks of poor filtration , allowing for viral particle penetration that would prove ineffective to protect the user against the Covid-19 virus . Consumers are therefore strongly advised to buy SIRIM QAS certified face masks to ensure adequate protection against the transmission of viruses , bacteria or infections .
The Testing , Inspection and Certification body said there is already a credible international standard for face masks — the BS EN 14683:2019-Medical face masks . Requirements and test methods — and that it is ready to perform product testing and certification to ensure that products in the marketplace are up to mark .
Compliance perimeters
SIRIM QAS uses several technologies when it comes to testing . For medical face masks , it tests them for their Bacterial Filtration Efficiency ( BFE ), Differential Pressure , Splash Resistance Pressure ( Synthetic Blood ) and Microbial Cleanliness ( Bioburden ).
Through testing and certification of above parameters , the compliance of the parameters is determined based on minimum or maximum limit it needs to meet . For example , its Bacterial Filtration Efficiency ( BFE ) property needs to be at least 95 per cent while Deferential Pressure or Breathability needs to be less than 40 Pa / cm . sq .
SIRIM QAS says its face mask testing and product certification process for manufacturers provides assurances of safety and reliability to users .
“ Our testing provides independent assurance that your products are manufactured under an effective system of testing , supervision and control . Thus , there is improved production efficiency and reduced wastage and rejects . It also demonstrates product compliance with national or international standards , ensuring your product functions effectively and safely while enhancing your reputation and extending your market by using the Product Certification MS trademark and security label on your certified products as a marketing tool ,” it said in a recent statement .
With the rising concerns about the current health situation , product conformity can provide assurance to the general public that standards of quality are consistently maintained . It enables manufacturers and suppliers to differentiate their products in the market and gain consumer acceptance .
Dangers of substandard face masks
The final decision is at the hands of consumers . They should avoid substandard products although they are cheaper , and instead look out for masks that have the MS trademark and security label by SIRIM QAS on them . With the MS trademark and security label on products , consumers will be able to identify quality and effective products among the mountains of options available in the market . Furthermore , the security label comes with a QR code where customers are easily able to scan and obtain certification information .
“ Substandard medical face masks expose users to Covid-19 , as they may allow viral particle penetration . Substandard face masks may be made from materials that are unsuitable for our skin and cause skin allergy . There are also risks of being infected with the virus , owing to the absence of proper filtration , a key part of the medical device ,” SIRIM QAS notes .
Currently , SIRIM QAS provides a 20 per cent rebate to manufacturers of face masks under the package service for testing and certification , from June 15 until the end of the year , subject to terms and conditions .
Organisations interested in obtaining the face mask testing and certification can communicate directly with SIRIM QAS by visiting its website at www . sirim-qas . com . my , calling the Customer Service Section at 03-5544 6400 , or sending an email to cserviceqas @ sirim . my .