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Manufacturing

From raw material to sealed drum, on Biomed’s own sites.

Biomed manufactures at two units in Andhra Pradesh. Processing, drying, testing, storage and packing are all carried out in-house, with dedicated R&D, quality control and microbiology laboratories.

Illustration of a line of glass-lined reactors

Manufacturing process

Six stages, all in-house

Every stage below happens inside a Biomed unit, so each batch stays under one quality system from start to finish.

  1. Raw material receipt

    Each lot is sampled and tested before use, and recorded against its supplier and date of receipt.

  2. Extraction & hydrolysis

    Enzymatic, acid or alkaline hydrolysis releases the target molecule from cartilage, hide, fish skin, chitin or bile.

  3. Separation & purification

    Filtration, precipitation and crystallisation steps, as each product requires, bring it to its specified assay and purity.

  4. Drying

    Spray dryers for Collagen and Chondroitin; an agitated Nutsche filter dryer (ANFD) for crystalline products.

  5. Testing & release

    Finished batches are tested in the QC lab and released by QA with a Certificate of Analysis.

  6. Packing & dispatch

    Standard packs are 25 kg and 50 kg net, in fibre drums with double polyethylene liners. Other pack sizes and custom labels on request.

Equipment & laboratories

What each batch passes through

Processing

  • Spray dryersCollagen Peptides and Chondroitin
  • Agitated Nutsche filter dryer (ANFD)Crystalline products
  • Reactors and extraction vessels

Quality control lab

  • Shimadzu HPLC
  • Gas chromatography (GC)
  • UV-visible spectrophotometer
  • Digital polarimeter21 CFR Part 11 compliant

Microbiology lab

  • Dedicated, separate laboratory
  • Microbial limits testing on finished products

Stability

  • Stability chambers at several storage conditions
  • Ongoing stability data for each product

R&D

  • In-house lab for process and product development
  • Custom molecular weight, particle size and assay

Inside the plant

Photo gallery

Production

Reaction and extraction vessels in the production hall
Reaction and extraction vessels in the production hall
Spray dryer chamber
Spray dryer chamber
Spray dryer
Spray dryer
Agitated Nutsche filter dryer (ANFD)
Agitated Nutsche filter dryer (ANFD)
Fluid bed processor
Fluid bed processor

Clean areas and material control

Clean-area corridor
Clean-area corridor
Approved-material area
Approved-material area
Quarantine area
Quarantine area

More from the plant

Glass-lined reactor
Glass-lined reactor
Pulveriser
Pulveriser
Multi mill
Multi mill
Sifter
Sifter
Blender
Blender
Cooling towers
Cooling towers