Infrastructure Quality Policy

How we ensure Quality?

We pride ourselves on our quality.

We understand that our products are in one way a summation of the raw materials we use. We make sure to source from well reputed vendors with a history of delivering quality products and we have a stringent in house testing for all our raw material supplies.

How we minimize risk in Production?

We minimize risk in the production of our products by ensuring:

  • Separate dedicated Air Handling Units (Class 100,000 with 0.3 Micron HEPA Filter in terminal) for production, sampling and dispensing rooms
  • Continuous loop Reverse Osmosis plant (to avoid any microbial growth conducive to stagnant water) with online conductivity meter, 5 micron filter, UV light and thorough water validation processes
  • Separate sampling booths for raw materials
  • Separate entry for man and material for raw material sampling, dispensing and production areas. Unilateral flow of man and material
  • Dust Extraction systems in production areas and coving on floors and ceilings of production, sampling and dispensing areas
  • Dedicated gowning for each production area

Production of each batch is followed immediately by:

Rigorous Testing of finished product

We have a strong team of Quality Control personnel, Quality Assurance personnel and specialized Microbiologists. Our Quality Control team takes samples of each production batch at every stage of production and runs tests under multiple parameters set by the Indian Pharmacopoeia, British Pharmacopoeia and United States Pharmacopeia. In addition to compliance with these Pharmacopoeia institutions, we also run various in-house tests to ensure the batch matches the highest quality standards.

Our laboratory consists of

  • Chemical Analysis
  • Microbiology
  • Instrumental Analysis
  • Stability Section

To ensure the shelf life of our products, we have been carrying out stability study under guidelines set by the World Health Organization and International Council for Harmonization.

Raw Materials

In addition to final product testing, all our raw material is thoroughly tested to ensure purity and efficacy. If any defective supplies are detected, they are immediately returned or discarded.

For a long time, it had been very difficult for us to source quality sodium bicarbonate for our products. Sodium bicarbonate is a key raw material used in the production of the base part of Haemodialysis. The best available material earlier, although within range of the guidelines offered by the Indian Pharmacopoeia and British Pharmacopoeia was on the higher side in heavy metals like iron, various sulphates, calcium and chloride (According to the guidelines set by the International Society of Nephrology). High levels of calcium can cause various side effects in patients like vascular calcification and adynamic bone disease. Similarly high levels of can increase risks of metabolic acidosis and high levels of aluminium can increase risks of neurological deterioration and bone disease.

Using sodium bicarbonate that is completely free from these impurities is also beneficial for the dialysis machines. By eliminating impurities in sodium bicarbonate completely, there are fewer (if any) machine breakdowns, lower maintenance costs and longer lives. This is because impurities block the dialysis membrane and the precipitate formation on the pump leads to non uniform dialysis flow reducing the efficiency and performance of the dialysis machines.

Aware of this problem but short of reliable quality sodium bicarbonate suppliers, we were actively looking for Sodium Bicarbonate in its purest form, free from any toxic heavy metals or impurities of any kind.

Somewhere around that time Tata Chemicals started producing a new line of pharmaceutical grade Sodium Bicarbonate with such purity that most impurities and toxic heavy metals tested to almost negligible levels. Various independent labs corroborated this and we decided to start using Tata Medikarb for our sodium bicarbonate supplies.

We entered into an exclusive partnership with Tata Chemical for Medikarb Sodium Bicarbonate manufactured in Gujarat, India. Tata manufactures sodium bicarbonate in an AHU classified class 100,000 area with 0.3 micron HEPA filters. The result is a clear, uniform free flowing crystalline powder that is free from toxic impurities and dissolves readily in water. We use this to make our product of the highest quality and ensure a smooth and effective dialysis for our patients. This eliminates the risk of adverse reactions that could take place on some patients during dialysis and increases the lives of the dialysis machines. Patients and doctors will feel a tangible benefit of this change over time.


 
 

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