Process

Manufacturing Site

The manufacturing plant and process is designed in accordance to the GMP guidelines and the factory is WHO:GMP certified. The factory is operating in a clean environment and the plant is treated with pest control in order to maintain lower than the admissible limit of bio burden. The plant has proper lighting, guidance and proper entry and exit points as per GMP guidelines to manufacture a medical device.

Latex sourcing

The centrifuged 60% Dry rubber content Natural rubber latex is obtained locally from the rubber plantations in centre Travancore in Kerala State. Proper in house lab testing are done before approving any batches to our manufacturing site. For Specialty gloves production we use double centrifuged latex which gives low protein and high Dry Rubber Content.

In general the following levels are set as our standards for sourcing latex

Chemicals used and compounding: Our quality team performs tests and selects non-toxic chemicals to rubber (glove) which have a safe concentration levels that are used in the manufacturing process. The desired concentration levels of each chemicals used in the compounding are formulated by our team due to more than than 2 decades of experience in the glove manufacturing process. We use only approved chemicals from the drug department of India and we do not use chemicals that are extracted from animal tissues for our production.

Vulcanization and leaching: Our line is a hybrid line in which we have the resource to vulcanise the rubber gloves with Furnace oil boiler and Gas system (PNG). We don’t use fire wood boiler unlike our competitors and our team believes in green earth system. During treatment with sulphur in the line 90- 95% of leaching is achieved and rest 5-10% is achieved during tumbling. Ambient air temperature is set inside the line which results in the curing of the glove and high tensile strength. We use chemical leaching and anti bacterial solutions are used during the process and we use treated water in the compounding and also in the line. The precanceling and post leaching temperature in the line is 80-85°c.

Powdered gloves: The powdering of the gloves is done in the powder tank in the line, where USP grade corn starch is used. The powdered tanks are strictly monitored to ensure that there is no bacteria growth. The powder content in the gloves are less than 10 dm/cm².

Powder free gloves: To make gloves powder free, we wash, bleach it with chlorine, neutralize, rinse and we dry the gloves. The chlorinated powder free is most ideal form of powder free gloves. Aesthetically for off white colour finish we make polymer powder free gloves as well. We wash the gloves thoroughly with chemicals to achieve less than 50 mg/dm².

INSPECTION:

100% of the gloves coming from the production site is tested for pinhole by air test. Random sampling of the each lot of production is tested for Physical parameters, tensile strength and chemical properties on the glove is done in our inhouse lab. In our QC process the gloves are inspected at 4 stages to ensure pinhole free gloves as per the specification.

Online inspection of the glove is done at the time of production to ensure the quality of the product at the production level. The lab tests are done here for each lot.

100 % Inspection: Every single piece of glove is air tested to ensure no holes in the system and it is passed down to the packaging team. Random sampling is done for water test and AQL is followed according to the ISO sampling level.

Random sampling, inspection and QC is done by the packaging team before packing. This is the third round of inspection.

Pre-shipment inspection is also done and random sampling is done before dispatching the goods.

PACKING

The Packaging is handled by our packing team in another building. We have a clean room for the packing of the glove. The clean room is as per Class 10000. The air pressure filter systems are there to control and maintain the level inside the room. This is done to ensure that the gloves supplied is fit for clean room usage. No bacteria or contaminants comes in contact with the glove. The walleting process is done manually by labor and the pouching is done by the pouch sealing conveyor machine. Regarding the packaging we use paper as per the EN 868 and we craft paper for the box and carton that have sufficient break strength and sterilization permeability.