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OUR QUALITY STANDARDS PRODUCTS

 

Statutory Approvals

The manufacturing plant has been licensed by the Central and State Governments, controlled by the Director of Industries and Commerce. The company is registered with APEDA (Agriculture and processed Food Products Export Development Authority) vide registration number APEDA / REGN / IMP / 031339 / 2001 dt. 26.12.2001 and is accredited by CHEMIXCEL.

The factory and premises have all necessary statutory approvals under the State Factories Act and Central & State Commercial Taxes Act and has been accorded consent to operate, by the pollution Control authorities of the state so also by the local Government authorities. Senthil papain is registered with the Ministry of Commerce, Govt. of india and is accorded with Import and Export code 3294002637. Being a member of the International Exporting community, it is recognised by the HS Code No. 35079003 (Hormonised system of nomenclature)

Quality Policy

The company endeavors to assure that the quality of the products produced are of the highest standards as per the International norms as given in the Indian Pharmacophia and the other out. Manufacturing top quality papain is not only a virtue but also way of life.

QUALITY - MADE TO INTERNATIONAL STANDARDS

PRODUCT
ULTRA REFINED PAPAIN POWDER
SEMI-REFINED PAPAIN POWDER
LOW ACTIVITY PAPAIN POWDER
Process
Spray Dried
Spray Dried
Spray Dried
Proteolytic Activity TU/mg Min. 1000 Min. 600 Min. 100 TU/ mg as per customer Satisfaction
Moisture Content Max. 4% Max. 4% Max. 4%
Mineral Content 10-6% -- --
Total Plate Count Cfu/gm Below 100 Below 2000 Below 100
Pathogens Absent Absent Absent
pH of 5% solution 5-5.5% 5.5-6% --
Specific gravity 0.4-0.45 -- --
Yeast & Mold Blow 25 cfu/gm -- --
Lead, Arsenic & Heavy metals Below detectable levels Below detectable levels Below detectable levels


Papain powder manufactured conforms to the following standards :

  • FCC IV regulations, USA

  •  
  • Jefca Recommendations

  •  
  • Indian Pharmacopoeia recommendations

  •  
  • FDA, USA
The standards adopted and used for assay:
 
  • EDC, USA
Estimation of Proteolytic activity
  • FDA, USA
Microbiological Assay (Total Plate Count)
  • BIS, India
  • Indian Pharmacopoeia, India
 


 
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