QUALITY CONTROL IN PRODUCTION

PRODUCTION OF NATUZYME

Fermenting using GRAS STATUS produces the active enzymes like Xylanase ,Amylase, Pectinase within the Natuzyme range (FDA – USA- approved microorganism) microbial strain: Trichoderma Longibrachiatum or resei (CBS 529.94).

GOOD MANUFACTURING PRACTICE (GMP) and ISO 9002 in microbial feed grade enzyme production is maintained through the whole process.

The fermentation feed stocks is sterilized prior to use: Autoclave at 121 °C 50 minutes and membrane filtration 0.22µ. After fermentation the microbial cells are totally separated by centrifugation. The supernatant is concentrated by ultrafiltration and resulting only enzyme liquid is spray-dried.


The Natuzyme  pass the FCC (USA analytical specification for food grade enzymes)/JECTA/WHO recommendations for feed processing enzymes.
They are classified in IUB and EINECS and CAS. They are on the EU list for accepted enzymes in feeding stuff.
GMP in the microbial feed enzyme industry ensures that enzyme preparations are produced, packed and handled in a hygienic way.
All operations are designed to avoid contamination, formation of undesirable by-products, deterioration and handling errors.
The principles of GMP include systems of quality control assurance, employee qualifications, maintenance standards for equipment, control of raw materials and product stability:
Identity control and laboratory management of the production strain.
Control of pure culture and operational parameters during fermentation.
Hygienic control during enzyme recovery .


The Natuzyme is packed in an automatic computer controlled packaging line into three fold paper and one fold PE ( polyethylene.) bags, which are sealed at both ends.
The pallet is shrink-wrapped with several layers against moisture. Shipping mark is attached.
The Natuzyme is assayed for pharmacological, microbiological, toxicological, physico-chemical quality including TVC (total viable counts), coliforms and salmonella and heavy metals including lead, and for enzyme activity ( a C/A and C/F is issued) before being passed by QC.


QC Department.

Bioproton Pty Ltd.

13/05/04  Brisbane, AUSTRALIA





Web site: www.uq.net.au/bioproton/ Trademark: "NATUZYME"