The most common personal protective equipment, or barrier used today in healthcare is gloves. The most important reason why a healthcare personnel wears a pair of gloves (sterile and non-sterile) is to prevent transmission of microorganisms and infectious materials to and from the patient. With the onset of HIV and the fear among healthcare providers about cross contamination, the use of natural rubber latex (NR) gloves has proliferated. These gloves (surgical and examination) have been universally preferred over the years because of their excellent barrier performance, among other beneficial properties.
Over the years, owing to adverse effects of pollution, the public has become very environment conscious. There is now an increasing pressure for consumer goods to be made of green materials. Unlike synthetic alternatives, NR latex gloves are made from an inherently environmentally friendly material. Natural rubber itself is a sustainable and renewable resource. The rubber trees have been estimated to remove 363 million kilograms of carbon dioxide from the atmosphere annually, and replace it with life saving oxygen. This helps to combat the green house effect and the global warming, which are of great concern to the world ecologists.
The process of manufacturing NR latex gloves are also relatively safe, in contrast to producing synthetic gloves which often involve the use of hazardous chemicals. NR latex gloves will also not contribute to pollution since it is biodegradable.
The basic raw material for glove manufacturing is natural latex that comes from rubber trees. Latex is a white, milky liquid that flows from the tree when the tree bark is scored (or shaved) and flows into a collection device that is attached to the tree. The collected raw latex is centrifuged to remove water, proteins and other impurities. Ammonia is added to preserve the latex for its trip to the factory or storage.
With latex, up to a dozen chemicals are added, including accelerators (which help control the latex vulcanization process) and anti-oxidants (which prevent deterioration of the rubber molecules in the final product by heat, moisture, and ozone).All the raw materials to be mixed with the latex are tested to verify that it is within the required specification. After the mixing, the latex compound is again tested before it will be used in the process.
This is one of the many QC stages implemented by SMSMCO to maintain consistent quality of gloves and keep rejection rates at minimum levels.
Good Manufacturing Practice is the basis of efficient quality control. Care, hygiene and extensive control arrangements during the whole process secure high quality.
The hand shaped formers are coated with coagulant and dried then dipped into the latex compound to coat the former with a thin film of latex. The thin film of latex is then partially dried then leached several times to removed water extractable proteins and maintain at the required level. It then passes to several drying and vulcanization process and donning powder coating until the final product is produced.
Gloves Production Line
Inspection and Testing
SMSMCO follows specific product standards recognized and accepted by the industry. A well established quality control system is implemented adhering to the requirements of ASTM, ISO and EN standards. These standards put some requirements on the allowable defects as well as physical properties of the gloves.
Gloves produced by SMSMCO are 100% electronically inspected to check the barrier integrity and other visual defects that will render the gloves useless for its intended use as a protection of the user to harmful and infectious diseases .
The 100% electronic testing is done using highly efficient computerized airtight testing machines that can guarantee AQL lower than 0.65. With the lower AQL implemented by SMSMCO, customers can be assured of a good quality of gloves supplied at par with leading brands.
The strict quality control implemented by SMSMCO ranges from Laboratory testing on the product which is done in-house and by an independent laboratory to confirm that the gloves produced are conforming to the specifications conforming to regulatory requirements. SMSMCO uses an inspection plan of G-1, AQL 0.65 for pinholes and other visual defects which is way above the requirements of the Industry specific standards.
The Average Quality Level (AQL) is a statistical standard defined by industry organizations, customers and manufacturers. Inspection levels or sampling plans are defined to determine pass or failure during quality control. The lower the Average Quality Level, the more consistent the product quality will be. The larger the sampling plans (inspection levels) the lower the chance of overlooking defective product batches
Electronic Airtight Testing
Packing
After the surgical gloves are 100% electronically inspected for pinholes and other visual defects, the gloves are packed. The packing activity involves using automatic packing machines for packing the gloves in inner wallets and closed outer wallets to maintain sterility. QC inspection is done at this stage to verify the quality of gloves. The papers used to pack the gloves are special grades of paper only used for medical applications. As a safety feature of the product, the outer packet is tamper proof that once opened it cannot be closed back again.
Packing Process
Sterilization
After the gloves are sealed in the pouch, it is packed to a box containing 50 pairs. Each pack is visually inspected for seal quality and random samples are drawn for leak testing to check sealing integrity. Eight boxes are packed in a shipping carton ready for the next process of sterilization.
The company uses EOG sterilization to sterilize the gloves. The sterilization process used by SMSMCO is properly validated to conform to regulatory requirements for Ethylene Oxide Sterilization.
Ethylene Oxide Sterilization Process
