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Medical Products at par with the best in the world
Manufacturing Facility
We have acquired immense capabilities in manufacturing high quality surgical consumables and allied products cost-efficiently. From the days of importing technology, we have grown to conceive product innovations in tandem with current needs. Foldable lenses, preservative-free Triamcinolone Acetonide, absorbable suture needles etc are a few of them.
Aurolab has constantly upgraded and invested in instruments and machinery like ultra precision CNC lathe machines to meet specifications accurately. Superior technologies like polymer technology for making hydrophobic lenses are being employed here. We have invested in high tech devices like interferometer, photo analysers etc. to ensure the quality of products. A dedicated and well trained production team plays a major role in efficient handling the manufacturing process. Various certifications like ISO, GMP, etc. hold evidence to the effective quality system in place covering the entire manufacturing process. A file is maintained for each batch, products, details regarding lot number, serial number, date and other manufacturing information are clearly documented and maintained in the file.
Our manufacturing expertise has also transcended ophthalmic products. This is cleared indicated by the successful development of suture needles for cardio vascular segments and 70-micron suture needles for microsurgery clearly indicates this.
Research & Development
Aurolab continues to invest in R&D activities to develop innovative products in line with the latest advancements and techniques. We have always remained ardent to address the pressing problems in eye care, which has put us at our innovative best in coming up with cutting edge products. Successful designing of 360 degree square edge in PMMA single piece lens, import substitutes for retinal drugs by the pharmaceutical division are a few of them. We have applied for patents for our innovations and have been granted intellectual property rights for the same.
Aurolab works closely with the doctors of Aravind Eye Hospital and leading surgeons in the country in developing new products. We are working on high technology products like Phaco, Toric IOLs, and Silicone balls.
A well designed polymer lab is also actively functioning since 2005 at Aurolab. This department has successfully developed high quality polymer sheet for hydrophobic foldable intraocular lenses.
Aurolab is also working on moulded IOLs. This technology of moulding IOLs is a unique one and very few companies in the world have this technology. This would give Aurolab a competitive edge over its competitors.
Clinical Research
An in-house Clinical Research Department with professionally qualified staff at Aurolab enables better coordination in handling all activities related to clinical research concerning a product. These studies are undertaken to authentically ensure the safety and efficacy of the product before being used on the patient.
Clinical trials from Phase I, Phase II and Phase III out by this department on new products prior to product launch and on the existing products. Phase IV studies are being carried for the entire product after the product launch in the market. Randomized controlled trials and double blinded tests are conducted for the products. Clinical investigational plan, patient’s information and clinical data are being prepared in accordance with the standards. Constant interaction with the doctors pursuing the study and focused efforts result in efficient planning, better execution and timely completion of the study as well as achieving reliable results.
Microbiology
Being a responsible implantable medical devices and drugs manufacturer, we leave no stone unturned to ensure the sterility of the products and packaging material. A qualified team of microbiologists in this department strictly monitors and validates clean room environment in the production area, analyses bio burden levels prior to and after sterilization, monitors and checks water systems etc. Confirming sterility on every batch of products before release is one of the crucial functions handled by this team. This department also ensures high personal hygiene levels of the production staff and their adherence to clean room standards inside the production area.
Regulatory Affairs
This department regulates the various concerned activities in compliance with the national and international standards, which in turn ensure safety and efficacy of the products manufactured at Aurolab. This department monitors certain important activities like necessary tests to be performed before product launch, labeling information of products, computerized documentation of the processes related to the production until the life of the product, internal and external audits, registration of products in various countries etc.
Finished Goods Maintenance
The finished products are systematically stored with an effectively implemented barcode scanning system. This system is absolutely foolproof in the stocking and shipping out of these products. This ensures ready to hand information on stock position of various products at any point in time and helps determine delivery dates, alerting out-of-stock situations in advance and enables planning of production based on the stock position. The system greatly aids in traceability of the products whenever it is needed.
Trained Workforce
Close association with Aravind Eye Care System has helped our work force to understand the dynamics of the eye, surgeons’ comfort and patient satisfaction in a better manner and resulting in well designed products.