Process
Manufacturing
The 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 70-80℃. 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, US 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 ASTM D-3577 standard
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.
VULCANIZING / TUMBLER
QUALITY CONTROL
In addition to standard airtight watertight Test, each batch of glove is electronically tested for micropores. Even though the controlled production produces gloves with less than 1% pinholes, 100% inspection is being done, involving over 250 skilled and trained personnel to offer you a defect free glove with a factory A. Q. L. of less than 0.65, as against International Norms of 1.5.
The well equipped laboratory has all the facilities and equipment to test quality of raw materials, physical properties of gloves and protein content of gloves using a Spectrophotometer. Estimation of protein is done for every batch of gloves, as per ASTM – D5712 using Modified Lowry Method. The inhouse Microbiological Laboratory also monitors Bio-Burden Level and Sterility. The laboratory is equipped with Laminar air flow cabinet and is manned by trained and skilled microbiologists.
GMP FOR SURGICAL GLOVES
A Glove is a protective device. A Surgical Glove is much more than a protective device – it is a MEDICAL DEVICE, used in invasive surgery in a sterile area. A good glove therefore should not have any bio irritants present on the glove, which can cause health hazards to user and patient. Natural Rubber Latex is the best Polymer for Surgical Glove as it provides optimum barrier properties, elasticity, comfort, fit and cost and has been used for Centuries.
However, recently Latex Gloves have come to be associated with Latex Allergies. What causes the allergy? Is it Rubber Latex or the Manufacturing process adopted within the last two decades – first to meet increased demand and subsequently to reduce cost to sell gloves at a cheaper price due to competition, since supply currently exceeds demand?
It is the unscrupulous manufacturing practices that contribute to latex allergies from gloves. The critical parameters that need special controls, apart from the physical properties and dimension for Surgical Gloves are:
- BARRIER PROPERTIES
- BIO BURDEN LEVEL ON GLOVES
- BACTERIAL ENDOTOXIN LEVELS
- MOISTURE CONTENT ON GLOVES
- TOXICITY
- RUBBER CHEMICAL RESIDUE
- LEACHING AND QUALITY OF WATER USED
- EXTRACTABLE LATEX PROTEIN
- QUALITY AND QUANTITY OF DONNING POWDER
- PACKING MATERIAL AND PACKING SYSTEM
- STERILIZATION PROCESS AND STERILITY ASSURANCE
Packing
A separate building is engaged for housing the packing section into which only Quality Control passed gloves are allowed to enter. Packing Section is clean and dust free with positive pressure filtered air system with controlled exit and entry points. It is kept clean and fumigated at regular intervals to ensure low bio-burden level. State-of-the-art Packing Machines are installed for Walletting, Pouching and Sealing the gloves automatically thereby reducing human contact with the gloves to a minimum. The Walletting Machine prints and folds the wallets in-house thereby reducing contamination.
The Pouching Machine is specially designed for automatic packing of gloves. It incorporates skip sealing, photo electric cell for registration as well as a flexography system for printing of batch and other manufacturing details.
Moreover, the Pouching Machines ensure an aesthetic packing system and the integrity of the pouches. The entire process is done in a controlled and clean environment. The end result – very little chance of contamination and a great degree of hygiene. The packed gloves are once again quality assurance checked and passed for sterilization.
Sterilization
State-of-the-art P.L.C controlled E. T. O. Sterilization Plants with a double door system are installed which is validated to EN 550 Norms. Each process cycle’s efficiency is monitored with Bio-Monitors. The process cycle also includes sufficient Air Wash Cycle to ensure that residual E. O. on the glove is low.
The carefully selected packing material used ensures that it is suitable to permit E. O. sterilization and maintain sterility during transit and storage for the shelf life of the product. The sterilized gloves are tested for sterility in the in-house Micro Biological Laboratory. The finished goods are cleared by Quality Control Department for Quality Assurance and undergoes Consignment Audit which includes:
- Correctness of quality, type and sizes as per order
- Correctness in pairing
- Correctness of stamping particulars
- Correctness of packing materials
- Correctness of marking on pouch / box
- Conformance to specifications of the relevant grade of gloves
- Compliance to all previous inspection and test requirements
Only the gloves which pass the specifications are transferred to the warehouse for shipment.
Warehousing
We have a Large Warehouse with the capacity to store over Two Million Pairs of gloves. The Warehouse is regularly pest controlled and fumigated to keep it pest and insect free.
The Master Cartons are sealed with colored tapes, with each color representing a particular size. This allows instant identification of size to our clients. The quality assurance passed gloves are container stuffed from the warehouse and shipped all over the world.