1. your sucralose does drinking water is used in the production
process? Testing yet? How long the test? Did he comply with local law
requirements? Purification of water used in the production process, according to
the Chinese Pharmacopoeia requirements detection, purification of water quality
in line with the Chinese Pharmacopoeia requirements to meet drinking water
standards, the company quality assurance testing, while also sending external
detection. Pure rooms total, total back to and tank testing inspection once a
week, workshop each detection point inspection once a month, third party testing
is testing once a year
2. how to prevent chemical hazards during production?
Such as allergens, disinfectant, toxic substances (such as migrating from the
packaging), pesticides, heavy metals, antibiotics? All using chemical raw
materials in the production process, no animal raw materials of domestic plants,
so there is no hazard of pesticides and antibiotics, allergen-free hazard.
Expressly set forth disinfectant concentration and frequency of use, and
regularly check the usage. Were included in the hazard analysis on the hazard
analysis of packaging material, all bags must be in food grade packaging
materials and packaging materials procurement to each batch plant must be
detected by the QA sampling, sampling QC, QA department release must be reported
as finished. Prevent harm to physical or chemical or other product packaging
materials. Hazard analysis of the production of all raw materials used,
including heavy metals, for focus, the key raw material for heavy metal
detection, ensure that their heavy metal content must conform to the technical
requirements of the standard. Antibiotics are not used in the production process
raw materials.
3. how to prevent physical harm in the production process? Such
as pests, hair, glass, wood, metal? Entrance and finishing, drying and packing
and general area for production workshop runway killing lamp is installed,
production cloth mouse pad. Warehouse equipped with the killing lights, rat and
mouse plate to prevent rat pest. Rat pest control files are in place, QA
supervision and inspection in accordance with this file execution Lamp shields,
glass has explosion-proof membrane, preventing harm product Establish a metal
weapon list for each workshop, and checking every day, do a check record All
incoming and outgoing finishing, drying and packing a clean area must wear clean
clothing, hats, masks and clean shoes, washing, disinfection to enter. Workshop
site such as wooden pallets are not allowed.
4. how to prevent microbiological
hazards in the production process? Such as Escherichia coli, Staphylococcus
aureus, Bacillus cereus Enterobacteriaceae, mycotoxins No animal or vegetable
raw materials in the production process and production process is chemical
synthesis process, PH and temperature environment of production does not make in
microbial production and inventory, the company quality assurance process water
and microbial detection products on a regular basis.
5. dealing with a sieve:
foreign body contamination? Sieve mesh number is how much? In the process used
to sieve? Of sucralose production process screen sieve mesh 16-100 purpose.
Sieve and use prior to use has to check its integrity, to clean the screen after
each screening.
6. a few steps in the production process is how long to heat
heating? Temperature? Esterification of high temperature autoclave liquid
warming to 110~115â chloride, keep the temperature a certain amount of time,
pour and kettle Removal of DMF heating under vacuum removal of DMF Deacetylation
enrichment: dehydration under vacuum, and serve into the crystallization
cauldron
7. step in the production process is sterilized? Time? Temperature?
Officers must change clothes before entering the finishing, drying and packing
in clean area, washing hand and disinfection. After each batch of material
production, the production equipment must be cleaned, disinfected.
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