Most of the enzymes used by us are Genetically Engineered (GE) grade from the best sources across the globe leading to high sensitivity, specificity and performance characteristics. We employ Zwitterionic buffers where enzymes, biochemicals, and co-factors exhibit consistent and stable performance. Quality of water is of utmost importance as it is over 90% in most of the reagents. The water used for manufacturing goes through a 5-step purification process to obtain the highest purity and lowest contaminants. Only 25% water is recovered after such tough process which qualifies for our use.
Our formulations have a very high conformation to international bodies like the International Federation of Clinical Chemistry (IFCC), German Society for Clinical Chemistry (GSCC or DGKC) and The Scandinavian Committee on Enzymes (SCE) making our products acceptable to international standards
QA and QC protocols:
Global quality is our philosophy. We have developed our internal QC specifications which not only check the quantities of components in the reagent systems but also checks their functional performance and characteristics, which is unique to us. We also check other parameters of the reagent systems such as pH, blank of the reagent, shelf life study at different temperatures, accelerated stability study, etc. Every batch of products manufactured gets tested against 4 independent third-party controls of normal as well as pathological range. Only upon satisfactory performance, the product is released into the market.
We employ packaging materials from reputable sources through strict vendor and material specification criteria. All of our plastic and glass materials are made from virgin raw materials. Stringent 4-step washing procedure makes our materials inert and leach-proof. We also have strict leakage and breakage tests to ensure the packaging material does not compromise on our reagent quality. In few cases, we have developed customized packaging materials as per customer demands to ensure temperature stability and protection for long-distance transports.
All the products are manufactured under controlled environments such as particle-free zones, low humidity chambers, and low total microbial counts. Our high-end sophisticated equipment is well maintained and well calibrated to ensure precise specifications of volumes and purity. Finished products or goods in the process are stored only in virgin plastic containers having desirable specifications. Regular disinfection of manufacturing rooms and equipment are employed to ensure minimum breakdowns. We also have multiple checkpoints or Quality-planning tools, such as the chart of operating specifications, which act as a platform at various stages of manufacturing processes to ensure the best product that meets all the required specifications gets passed as a final product and reduce rejections.
Our storage space spans about 700 sq. ft. in an area which is has controlled environment of temperature, humidity, and light. Proper classification of sub-areas helps to assign and keep the products in designated areas and their easy retrieval.
We have separate shipment partners for multiple geographical territories domestic and abroad that meet our requirements of time of deliveries, transport temperatures, etc. All our shipment partners have efficient web-based tracking systems of consignments.In the end, We believe quality is not a static concept but needs continuous improvements to meet newer demands and challenges offered by changing markets, customers and pathogens and diseases.