MANUFACTURINGThe manufacturing environment and process has been designed to achieve the critical in-built quality that is necessary in a MEDICAL DEVICE as per GMP requirements.
The factory has a clean, hygienic, dust free, manufacturing environment. The plant is completely closed and the factory has controlled exit and entry points with positive air filtered system as per GMP guidelines for the manufacture of a MEDICAL DEVICE. This ensures that the gloves are uncontaminated with a Low Bio Burden.
- IN-HOUSE COMPOUNDING Carefully selected Non-Toxic Rubber Chemicals with safe levels of concentration are used for the process. The compounded latex is further clarified to remove excess chemicals if any. All raw materials used are Quality Assurance inspected and only materials of the highest standards are used.
- PRE-LEACH, VULCANIZING, POST LEACH
The beaded gloves are Pre-Leached in 80 ft. of treated hot water to wash off non-rubber particles and rubber chemical residues that could otherwise remain on the glove and can cause allergic contact dermatitis. The water used in the leaching tanks are treated to prevent bacterial contamination and heated to improve leaching efficiency. The system includes four Pre-Leach tanks of hot flowing water which are constantly monitored to meet required parameters.
The gloves are properly Vulcanized to ensure best physical properties and to reduce moisture content. It is Post-Leached again in 60 ft. of hot flowing water at 70-800C. This washes off much of the extractable Water Soluble Latex Protein, Residual Chemicals and other non-rubber particles.
To offer you the best Bio-Compatible Gloves, with Pre and Post Leaching process, the consumption is over 150000 litres of bacteria treated water every day. Extensive Pre-Leaching, Post-Leaching and Vulcanizing are some of the critical measures taken to offer you a safer glove.
- POWDERING / STRIPPING Only imported, U.S. FDA approved Bio-Absorbable Dusting Powder USP is used to powder the gloves. The powder in the tanks are closely monitored and controlled for bacteria build up and protein content. The powder content on the glove is monitored to keep within levels as per standards of ASTM D-3577
- VULCANIZING / TUMBLER To reduce powder content in gloves to less than 15 mg/dm2 and reduce moisture level to less than 0.75%, the gloves are Tumbled in a validated process cycle with temperature and time critically controlled. High powder content and moisture can result in Microbial Growth, causing discoloration and unpleasant odour.
- POWDER FREE GLOVES
The Powder Free Gloves are processed in a special, separate area. To produce Powder Free Gloves, the Pre-Powdered Gloves are Washed, Chlorinated, Neutralized, Rinsed and Dried. The extractable latex protein content of these gloves is less than 50 mg/dm2.
Our plant also has the facility to make Polymer Coated Powder Free Surgical Gloves on line which has a better donning facility.