The manufacturing facilities plays the important role in regulatory approvals and compliances, failing which manufacturing facility may be rejected for approvals. The major aspects of the facility includes the Man and material movements, Equipment and utilities selections and their validations. Careful and studied approach for the facility design may avoid modifications and rejections of the facilities.

Processing and Reprocessing for Medical Plastic Devices

Medical devices need special attention. The commodity plastics like polyethylene and Polypropylene are used also for manufacturing of medical devices. However, the compounding and processing of base polymers require some precautions. The additives are selected carefully and so also finishing. The composition of body fluids is not  the same throughout the body. The implants have different requirements and standards depending upon the time necessary for the implants. Some of the devices are made from bio degradable polymers. The processing of biopolymers is different. Some aspects of processing and reprocessing are briefly discussed.

Quality testing of Polymer/Plastic material required for medical applications

There are small number of medical grade polymers available for medical applications and an even smaller number is used for implants. The choice of polymer depend on the extent of contact with body fluid, internal and external tissue. PVC PA, PE (LDPE, HDPE), PS, Epoxy resins used for syringe, blood bags, glucose drips. Silicon rubber, natural rubber, PVC, PU, PP, Nylon, Teflon used for catheters, feeding tubes, surgical instruments. Nylon, PP, Polyester for cultures & ligatures. PE, PET, PU, Silicon rubber are used for implants, drug delivery devices. To ensure the quality, testing of these polymers are to be undertaken for the chemical, mechanical, thermal & biocompatibility evaluation.

In SRI we perform the complete testing of these parameters as per USP chapter 661, 661.1, 161, 87, 88 & ISO 10993-1. A brief description of these parameters are Identification of Polymer by IR and DSC. Physico chemical parameters like Absorbance, Acidity/Alkalinity, non-volatile residue and TOC. Extractable like Phenolic antioxidants, non-phenolic antioxidants, amides, stearic acid & plastic additives etc. Extractable metals like Al, As, Ba, Cd, Co, Hg, Mn, Ni, Pb, Ti, V & Zn etc. Functionality/Mechanical tests like spectral transmission, tensile strength, MVTR. Biological reactivity in –vitro Cytotoxicity, Biological reactivity in-vivo, Systematic injection test in mice, intracutaneous reactivity test in Rabbits & Implantation test in Rats/Rabbits.

Non-Woven Medical Textiles – Opportunities And Challenges

In healthcare, nonwovens are utilized largely in products that are designed to provide barriers (e.g., barriers between patients and themselves, barriers between the patient and the physician/caregiver and barriers between healthcare workers). The Asia pacific medical nonwoven market is estimated to reach 3,374.9 million by 2020, registering a CAGR of 12.1% from 2015 to 2020. In India, only 12 percent of technical textiles products are manufactured by nonwoven technology as compared to 24 per cent of global consumption. The polymer and raw material required for that is now indigenously produced. The presentation is focused on details of non-woven medical textiles industry in India including raw materials, range of products, their manufacturing and end use.

Career Counseling for Life Science Skills - Building New India - "Sankalp Se Siddhi”

"A degree alone does not make a man educated”. It is the character of a man, who can change this world. Education must be rooted in firm Principles, Practical Knowledge and nurtured on Right Values.

Well identified gap between Academia and Industry is not the knowledge rather a skill set that is required to transform the academic knowledge in to Industrial application. Our “Young Indian Youths” are performing excellently globally provided they have acquired specialized skills apart from academic degrees by making extra  efforts for real time Learning and Development at an adequate Training and Development institution outside the conventional academic hubs.

No longer is a degree in Life Sciences, Chemical Sciences, Pharmacy and Medical Sciences considered only academic. These area of studies are the new hot area for career building, As Clinical Research, Ayurveda clinics proliferate, cosmetic procedures and transplant surgeries become mainstream and medical coding opens up opportunities, the demand for life science graduates has increased manifold.

We are becoming more rational using any product of day to day, our judgment is relying on scientific and clinically proven products and creating vacancies for people with science degrees.

With the leverages of Government of India in the Medical Devices sector, Make in India mission, Restructuring of Banking and Insurance Sector and Ayushman Bharat, the opportunities for Biomedical Technologists and Life Science students are on the top demand.

Medical coding is another avenue for this section of students. While the healthcare market in the US is maturing, companies in India are hiring Life science graduates and the requirement is not just in a newage professional set up, specialty hospitals need biomedical experts who can proof-read codes, "If you choose to work for a third-party administrator or an insurance company that reviews claims, medical knowledge is mandatory. Only then can you review the doctor's treatment, spot frauds, note if the drugs are relevant to the concerned surgery or being used to inflate the bill,”

The growing industry for virtual scribes, who support doctors in the US is also contributing the boost in science becoming a lucrative option. With Donald Trump's healthcare measures, the US doctors are now legally required to document and record every minute of their consultation and treatment process. "Virtual scribes have stepped in to take the heat of overworked doctors and Life sciences' students are the best hands. More than 50% of the hires are science students as they only have to be specialized skilled as they are aware of the medical terminology and jargon. Closer home, it's the Ayurveda hospitals that need people for documentation and prefer those with medical knowledge.

While startups in the online drug delivery space are hiring students for who can understand the drug market, recognize prescription drugs, place orders and stockpile based on demand, those with specializations are finding a place in niche areas like sports consultancy. "There is a demand for people who have an understanding of exercise medicine, physiotherapy, diets and muscular-skeleton issues. And life science students are a good fit for these areas," with adequate skills.