 |
|
Manufacturing Facilities.
Creative Drug Industry has established a state of art facility conforming to the exacting standards demanded by revised norms of FDA.
It has well designed manufacturing facilities comprising of raw material reception – processing- extracting-dispensing to deal with varied allergen raw materials like mites, pollens, fungi, dusts, insect, foods etc. Manufacturing areas are designed to facilitate unidirectional, easy and natural movements for men and material.
|
| |
| |
|
CREATIVE DRUG INDUSTRIES appreciates that the allergologist needs high quality, reliability and predictability from the allergens meant for patients who depend on him. There can be no compromise in the patient’s care, and we understand the crucial role of
our products and services in the system.
Highlights of the allergen technology adopted by CDI in the manufacture of diagnostic and therapeutic allergens are:
|
Quality Assurance :
From Raw Material to Final Product
Allergenic raw materials are obtained from the relevant sources with high degree of purity. Not more than 1% foreign pollens as determined by microscopic examination is allowed. 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 many tests performed on Allergen extracts during manufacturing are :
- pH: The pH of the final product is critical for the stability and solubility of acqueous allergens.
- Pyrogen Testing: Water used in manufacture of products meet strict standards to limit bacterial endotoxin.
- Ultrafiltration / Diafiltration: Ultrafiltration removes non-allergenic low molecular proteins and thus helps to enrich allergenic proteins by retaining high molecular proteins.
- Isoelectrofocusing: It is a useful tool to assure identity and quality of raw material and finished product. Isoelectrofocusing detects protein degradation, if any.
- Sterility testing: Allergen extracts undergo the same rigorous sterility testing as other sterile products for aerobic and anaerobic micro-organisms.
|
|
|
|
 |
|
Quality Assurance
Allergenic raw materials are obtained from the relevant sources with high degree of purity. Not more than 1% foreign pollens as determined by microscopic examination is allowed. |
|
Skin Test Allergens
Credisol Skin Test Antigens are aqueous allergen extracts containing 50% glycerine and preserved with 0.4% phenol with their strength expressed in Protein Nitrogen units (PNU). |
|
Aqueous Allergen Extracts
Credisol Aqueous Allergen Extracts ensure better treatment in allergic rhinitis and allergic bronchial asthama, and other allergic reactions to specific environmental allergens such as pollen, dust, mites, fungal spores, insect stings etc. |
|
Credisol Patch Test Allergen
Common causes of allergic contact dermatitis include lipsticks, cosmetics, hairdyes, necklaces, wrist watches, bracelets, industrial gloves, detergents, footwear etc. |
|
|
