CREATIVE DIAGNOSTIC MEDICARE®

The complete process from raw material to final product is closely monitored and controlled to ensure quality and purity of allergens.

 

Allergenic raw materials are obtained from relevant sources with high degree of purity. Pollen raw materials are collected and processed by qualified persons and collection methods conform to the standards laid down by WHO for collection and processing of allergenic pollen raw materials.

Mold allergens are derived from pure cultures. The cultures are grown in synthetic, non-allergenic, non-proteinaceous liquid media. Mites are grown and processed utilizing sophisticated technology developed by us in purview of quality standards laid down by WHO.

 

Controlled & Reproducible Processing 
Allergens are extracted under refrigeration temperature and strict environmental controls to minimize contamination and maximize allergenic activity. Allergens are extracted as individual components, avoiding unequal extraction of relevant allergens.

 

In-Process Testing

Some of the many tests performed on Allergen extracts during manufacturing are 

1. pH: The pH of the final product is critical for the stability and solubility of aqueous allergens.

2. Pyrogen  Testing: Water used in manufacture of products meets strict standards to limit bacterial endotoxin

3. Ultrafiltration / Diafiltration: Ultrafiltration removes non-allergenic low molecular proteins and thus helps to enrich allergenic proteins by retaining high molecular proteins.

4. Isoelectrofocusing: It is a useful tool to assure identity and quality of raw material and finished product. Isoelectrofocusing detects protein degradation, if any.

5. Sterility testing: Allergen extracts undergo the same rigorous sterility testing as other sterile products for aerobic and anaerobic micro-organisms.