Quality is an operational word in every sphere at Servo-Med. Our aim of customer satisfaction is achieved by ensuring that our products always meet customer needs; are always safe and offer desired performance, consistently.
Through training and monitoring this policy is understood and implemented at all levels of the organization.
We seek to be informed of developments in our field and continual improvement of our products and service is a credo we hold dear.
All this leads to the assurance that our products are in compliance with the quality requirements imposed for their intended use.
Quality System :
Quality Assurance includes documentation of each and every process from receiving of raw material to release of finished products. It includes controls with proper status labels at each and every stage of process of manufacturing as per standard norms and in-house procedure as well. It includes normal checks like bio-burden testing to minute check like presence of alkali in washings of components. Instruments used for relevant analysis are fully validated and calibrated.
Documents are being made and maintained properly. SOPs are available for each and every process. Outside agencies are also involved for maintaining standard conditions in factory premises self-auditing is done periodically to get better achievement and self improvement. Q. A. is responsible for both product quality and safety.
Testing : Testing is primarily divided into 3 parts Pre manufacturing, In process and Post manufacturing . Various types of physical, chemical and biological tests are undertaken at the above mentioned stages of manufacturing the same are listed hereunder.
Besides tests recommended in the Pharmacopoeia / statutory standards, we at Servo-Med have designed and developed testing procedures at all stages of manufacturing.
Pre-Manufacturing : - It contains testing of raw materials / packing materials prior to manufacturing. These tests include Physical testing, Chemical testing, Biological testing and special tests developed In-house.
Physical testing includes dimensions, size, gauge, grammage, text matter, color shade of components, and leakage tests of packing material.
Chemical testing includes shifting in pH, reading matter, nonvolatile matter, heavy metals test, light absorption test and other limit tests as per relevant IP & ISO standards.
Biological testing includes Intracutaneous test, Systemic injection test for PVC granules / tubings and drip-chambers and biological test A and B i.e. implantation test as per IP standards.
This test gives us good idea about the quality of raw materials. All raw materials are labeled as per their status. The under-test status may either be changed to release or rejected status after testing.
Leakage test is also done periodically.
In-process Testing :-
Relevant physical testing / checking carried out periodically.
Calibration / Validation of each and every instrument involved in manufacturing and testing is done periodically.
It includes testing of finished products. This is again divided into five parts Physical, Chemical, Biological, Microbiological and In-house testing.
Physical testing contains, dimension of components assembled as per ISO Standards Performance of the components as per requirement.
Chemical testing includes tests given in IP Standards and ISO Standards .
Biological testing contains pyrogen and toxicity test of the sets.
1) Sterility test of the product as per IP Standards using membrane filtration method.
2) Sterility test of biological indicators containing bacillus subtilis ATCC 9372.
Residual of ETO test as per ISO Standards
In-house testing :
Documentation of each and every of the above-mentioned tests are prepared and kept perfectly.
Performance test of each item manufactured
Control samples are also tested for stability study periodically.
Process evaluation and validation of ETO sterilizer are done periodically.