GOOD MANUFACTURING PRACTICE
We pursue Good Manufacturing Practice (GMP) by strictly adhering to the following principles.
1. PERSONAL & PERSONAL HYGIENE :
A well trained and qualified team is engaged in manufacturing and assembling of disposable products which is carried out in strict hygienic conditions. A disinfecting solution is used to wash hands prior to
commencing manufacturing. A special room is provided for pre-manufacturing change over which is
seperated from the main manufacturing area.
2. EQUIPMENT AND MACHINERY
The plant is designed to facilitate cleaning and to prevent foreign matter such as oil or other machine lubricants from contact with sub assemblies or other devices. This ensures minimum initial bio-burden
on each product.
3. RAW MATERIAL TESTING
MEDICAL GRADE NON TOXIC PVC is used which is tested in our laboratory for toxicity and grade prior to dispatch for processing.
4. IN PRODUCTION
Most stringent quality control standards are maintained during production. All products are assembled and packed in specially designed packing suitable for aseptic handling and storage.
5. QUALITY CONTROL
We maintain a strict quality control throughout from manufacturing to packaging. The quality control personnel are specifically trained and are approved by FDA (India).
6. STERILISATION
We maintain a state-of-art sterilisation plant, which is manned by Government approved FDA staff. All finished products are sterilised under E.O. gas at our plant. Gama Irradiation sterilisation is also
arranged, on specific request from customers.
7. ASSEMBLING AND PACKING
Assembling and packing is carried out in hygienic and air-conditioned rooms by well-trained team of workers.
8. FINISHED GOODS
Each batch of finished disposable devices are tested for sterility, undue toxicity and pyrogens. All these tests are carried out in our in house labs, as per the standards of Indian Pharmacopea or USP/BP.
In addition to the above tests, counter tests on random samples are conducted at independent testing agencies. A chart is maintained for each batch tested.
However we still need your valuable suggestions about our products to achieve perfection for better patient care.
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