Cml Biotech


Manufacturer of pre-analytical medical consumables and laboratory disposables based in Angamaly, Kerala, India. Operations include high-volume production of vacuum and non-vacuum blood collection tubes (multiple additives and gel-barrier variants), specimen collection swabs and transport media, prepared microbiology media, and a range of laboratory disposables. Facilities include ISO-class cleanrooms, automated injection-moulding and robotic assembly lines, dedicated microbiology production and QC laboratories, and quality management systems aligned with ISO 9001 and ISO 13485. Products are exported to 60+ countries.

Industries

Hospitals and Health Care

Nr. of Employees

large (251-1000)


Products

Blood collection tubes (vacuum and non-vacuum) — additive and gel variants

Range of blood collection tubes across multiple draw volumes and configurations with internal additives/coatings (EDTA K2/K3, Li+/Na+ heparin, sodium citrate 3.2/3.8%, ACD A/B, fluoride/oxalate, glucose preservatives), clot activators, serum/plasma separation gels, microtube variants and multiple cap/closure formats. Options available in PET, polypropylene and glass with elastomeric stoppers and sterile or gamma-sterilized pack variants. Typical storage 4–25 °C and shelf life ~24 months where specified.

Specimen collection swabs and transport media

Sterile specimen collection swabs (flocked and polyester) and a portfolio of transport media formats for virology and bacteriology, including viral transport medium and bacterial transport media and packaged collection kits.

Prepared plated media and dehydrated culture media

Ready-to-use plated media and dehydrated culture media for microbiological culture and identification, plus prepared broths and slants.

General laboratory disposables

Microcentrifuge tubes, centrifuge tubes, test tubes, petri plates, specimen containers, disposable pipettes, embedding cassettes and sample cups for analyzers.

Pre-analytical instruments

Devices for specimen handling including roller mixers, rotary mixers and syringe/needle destructors for specimen processing and waste handling.

Sodium Citrate 3.2

Sodium Citrate 3.2% tubes contain buffered Sodium Citrate solution provided in 3.2% and are used in routine coagulation tests.

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Expertise Areas

  • Blood collection device manufacturing
  • Microbiology consumables and culture media production
  • High-volume automated polymer processing and assembly
  • Cleanroom-based sterile consumable manufacturing
  • Show More (4)

Key Technologies

  • Automated injection molding for medical-grade polymers
  • Robotic assembly lines
  • Integrated automated tube production systems
  • Hot-runner mold systems
  • Show More (6)

News & Updates

Opening of a new microbiology department including ISO-class cleanrooms and expanded production/R&D capacity.

Commissioning of an integrated automated blood collection tube production machine and related assembly systems.

Agreement with an international sealing-solutions supplier for supply of rubber stoppers used in vacuum blood collection tubes.

Recognition for use of plastics in healthcare manufacturing.

Certificate of conformity to Council Directive on Medical Devices 93/42/EEC (Class I) — certificate assessed and issued; certificate number CE-3174, date of certification 31 May 2022 (subject to surveillance audits).

Licence to manufacture for sale or distribution of Class A/IVD medical devices issued under the Medical Devices Rules, 2017 (Licence Number: MFG/IVD/2022/000102).

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