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Production of Gloves
Manufacturing
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 transport or storage.
The quality of latex used in production has a direct
impact on the quality of gloves produced. SMSMCO uses
only Malaysian latex which is known to have the highest
quality of latex available.
To the latex, up to a dozen chemicals are added, including
accelerators (which help control the latex vulcanization
process) and anti-oxidants (which prevent deterioration
by heat, moisture, and ozone of the rubber molecules
in the final product.)
All the raw materials to be mixed with the latex are
tested to verify that they meet their required specifications.
After mixing, the latex compound is again tested before
it will be used in production.
This is one of the many Quality Control (QC) stages
maintained by SMSMCO to ensure superior quality of
our gloves. Rejection rates are kept 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.
Hand shaped formers of many sizes are coated with
a coagulant and dried. The formers are then dipped
into the latex compound to coat the formers with a
thin film of latex. The thin film is then partially
dried. They are then leached to remove water-extractable
proteins. The formers are then passed through several
drying and vulcanization processes finally coated with
powder to become the final product.
The whole process is controlled in order to maintain
the superb quality of our gloves. At every stage all
operating temperatures and conditions are recorded.
The final operation on the production line is cooling
down and stripping, i.e. removal of the gloves from
the formers. During stripping samples are drawn hourly
to verify the quality of gloves produced. If a deviation
is detected, corrective actions will be implemented
to the process immediately.
After production, gloves are transported on special
carts to our state of the art clean room where every
single glove is electronically tested, folded and packed
in the best of medical grade paper. The entire operation
takes place under the strictest hygienic conditions.
Our clean room is classified as Class 100,000.
Quality Control & Packing
After the surgical gloves are thoroughly airtight-inspected
electronically for pinholes and any other defects,
the gloves are packed. This activity entails the use
of automatic packing machines to place the gloves in
the inner compartments of their special packages and
then closing the package to maintain sterility.
After the gloves are packed in the inner compartments
and before their package is closed, another QC inspection
is completed to verify glove quality. An inspection
level of G-1 and AQL 0.65 is implemented at this stage.
The paper used to pack the gloves
is a special grade of paper used only for medical
products. The outside
of the package is tamper-proof: once opened, it cannot
be reclosed. The special packaging materials used for
the gloves are termed “cold seal.”
Sterilization
After the gloves are sealed in their packages. They
are placed in a box that will ultimately contain 50
pairs. Each pack is visually inspected for seal integrity.
Eight boxes are packed in a shipping carton. They are
then ready for the process of sterilization.
The company uses Ethylene Oxide Gas
(ETO) to sterilize the gloves. The sterilization process
used by SMSMCO
was properly validated to conform to ISO Standards
for ETO.
The process entails placing the boxes of gloves into
the sterilization vault. When closed the process of
sterilization is entirely completed and measured. Computer
validation is done frequently to ensure compliance
to the required standards of sterilization. Our process
has always been found to deliver required product sterility.
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