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 these lead to the assurance that the manufactured products are in compliance with the quality requirements imposed by 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 of each and every components, performance of critical components like roller clamps and three way luer slip etc. gauge, grammage, text matter, colour shade 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 IP 96 and IS 85364 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 96.

Special tests are being performed in-house periodically which includes the effect of PVC material on pH of normal saline solution, particulate matter test, self sealing capacity test for injection sites etc.

All these test gives us perfect 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.

In-process Testing :-

•  PVC tubings are checked strictly for its dimensions after each hour interval.

•  Assembled sets are tested for its length and presence of each component in the set after 30minutes each.

•  Plates of nutrient agar are exposed daily for checking bio-burden prior to and during assembling process.

•  Reading of manometer is checked regularly

•  Overprinted bags are also checked for the printed matter

•  For getting consistent result in sealing process. Sealed bags are also checked after each 30 minutes interval.

•  Quality of gas ETO injected and raise in pressure due to gas injection is also checked at the time of loading sterilizer.

•  BIS are kept at different spots for extra precaution

•  10 sets are checked for foreign particles, bending of tubing, proper sealing and damage due to sterilization process during visual checking process at each 1 hour interval.

•  Random samples are checked during packing too.

•  DM water is tested for pH and limit test given in IP 96

•  Rinsing of latex material are also checked for pressure of alkali during washing operations.

•  Random sampling is done during drying operations for tackiness.

•  Leakage test is also done periodically.

•  Growth promotion tests are also performed.

•  Calibration of each and every instrument involved in manufacturing and testing is done periodically.

Post Manufacturing

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 IS8536-4 Performance of the components as per requirement.

Chemical testing includes tests given in IP96 and IS 8536-4.

Biological testing contains pyrogen and toxicity test of the sets.

Micro-biological test:
1) Sterility test of the product as per IP 96 using membrane filtration method.
2) Sterility test of biological indicators containing bacillus subtilis ATCC 9372.

Residual of ETO test as per IS 8536.4

In-house testing :
•  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.