OEM

Our CDMO solutions enables companies to leverage our advanced manufacturing capabilities to produce high-quality medical devices under their own brand. We offer versatile capabilities and technologies within glass, plastic, metal and wire processing as well as plastic component molding, assembly, packing, sterilization and finishing.
Presentation video

Lancet needles

Lancet needles manufacturing portfolio

  • Silicone covered tip
  • Surface roughened by sandblasting or with LASER technology
  • End of lancet specially grinded to pencil point
  • Pre-sterilization by ETO in order to ensure low Cfu level
  • Final packing in CLEAN rooms class ISO 7 and/or ISO 8
  • Main angle from 6° with tolerance +/- 0,5°
  • 3-cycle cleaning procedure in special solutions together with ultrasonic
  • Siliconization min. at 5 mm length, silicone hardened
  • Packaging in magazines or bundles (plastic tins)

Lancet needles

• Made of EN 1.4301 (AISI 304) or 1.4310 (AISI 301) high precision stainless steel wires

• In diameter G33- G14 (from 0,2 mm till 2,0 mm) and in the lengths from 10 mm to maximum 120 mm

• Lancet tips:
>   Single bevel or 3-bevel tip with side- or back grinding
>   Trocar tip
>   Knife tip
• Manufactured in various surface roughening modifications as sand blasting or laser treatment, with or without siliconized point
• Production of lancet needles complies with the requirements of GMP and EN ISO 13485 standard
• Packing in clean rooms class ISO 7 and ISO 8
• Packed as a standard in small plastic containers of 50 mm diameter and in shipping cartons
• Possibility to agree on different packing of lancets according to the customer’s wish

Cannulas

Cannulas manufacturing portfolio

  • Silicone covered tip
  • Surface roughened by sandblasting or with LASER technology
  • End of lancet specially grinded to pencil point
  • Pre-sterilization by ETO in order to ensure low Cfu level
  • Final packing in CLEAN rooms class ISO 7 and/or ISO 8
  • Main angle from 6° with tolerance +/- 0,5°
  • 3-cycle cleaning procedure in special solutions together with ultrasonic
  • Siliconization min. at 5 mm length, silicone hardened
  • Packaging in magazines or bundles (plastic tins)

Cannulas needles

• Made in compliance with EN ISO 9626 standard using the state-of-the–art technology that ensures excellent sharpness of the point

• Made of medical stainless steel grade 1.4301 (AISI 304), 1.4306 (AISI 304L) or 1.4404 (AISI 316L)

• Manufactured in diameter G33-G10 (from 0,2 mm till 3,40 mm) in length from 9 -200 mm

• Rounded or chamfered cannula needle end, free of burrs

• One -or both side grinding using different bevels
> Single bevel or 3-bevel tip with side- or back grinding
> Tip with back eye or side hole
> Bent tip

• Packed in a plastic pots with foam protection against damage

• Supplied as non-siliconized, upon customer´s request can be supplied also siliconized cannula needles

Tubes

Tubes manufacturing portfolio

• Special technology of drawing in high precision and quality used for their production
• Produced from medically harmless steel of 1.4301 (AISI 304), 1.4306 (AISI 304L) or 1.4404 (AISI 316L) grade
• Outer diameter sizes from 33G up to 10G
• As a standard, the wall size in range of 0,07-0,02, 0,09-0,02; 0,11-0,02; 0,13-0,02, 0,15 or 0,16 -0,02 mm as calibrated wall and 0,20 +/-0,02 as non- calibrated wall, other wall thicknesses upon agreement available with tolerance limit
• Available in a winding, non-straightened in the lengths up to 5 000 m, or straightened in the lengths up to 3 000 mm

  • Packaging in magazines or bundles (plastic tins)

2-part disposable syringes

According to EN, ISO standards | Quality management certified according to EN ISO 13485:2016| CE marked

• ergonomic design, smooth flow, highly transparent barrel, tight
• black extended graduation, easy to read, double stop lines, guaranteed 0 ml position
• designed tip for best connection, double stop lines, scratch-free for glove manipulation
• available in Luer or Luer lock tip
• made of polypropylene/polyethylene, rubber-free
• pyrogen-free, latex-free, DEHP-free, PVC-free, non-toxic
• sterile, individually blister packed

Needles

According to EN, ISO standards | Quality management certified according to EN ISO 13485:2016 | CE marked

  • precision lancet point grinding, silicone treated for smooth penetration
  • colored coded transparent hub for flow visual control
  • included all metric and gauge measurements on all packages
  • mainly thin wall tube material
  • made of polypropylene hub and stainless steel tube
  • pyrogen-free, latex-free, DEHP-free, PVC-free, non-toxic
  • 100 pcs per box, 4000 pcs per case
  • sterile, individually blister packed

Plastic OEM manufacturing portfolio

  • manufacturing process available in clean room ISO 7 or ISO 8
  • plastic injection molding
  • asssembly and packaging
  • regulatory support and technical documentation
  • ETO sterilisation unit on site
  • possibility of different injection materials
  • mid-mass production technology, mass production technology capacities
  • support for assembly/packaging technology development

Accredited laboratory methods

  • Microbiological laboratory – an independent unit of the company CHIRANA T. Injecta a.s. performs microbiological, biological and physico-chemical tests of medical aids, samplings and analyses of working environment air and surfaces. Qualification to perform tests without prejudice, trustworthy, precisely, correctly and in required quality has the laboratory proved by fulfillment of requirements of the standard ISO/IEC 17025:2017 in 2019 and by obtaining the Accreditation Certificate no. S-264.
  • Employees of the laboratory take in their work advantage of their long-term experiences and expert knowledge in the field of tests of medical aids in accordance with European Pharmacopoeia and relevant international normative requirements, as well as monitoring of air-conditioned clean production premises and laminar boxes, with regard to microbial pollution and contamination by dust particles.

ETO Sterilization

There are four sterilization chambers available intended for sterilization by ethylene oxide with vacuum method. This method of sterilization is suitable for the sterilization of heat-sensitive products.Each of the sterilization chambers has utility capacity of 19000 litres, which represents internal dimensions of 2000x1900x5000 mm (H x W x D). 8 europallets can be inserted into one chamber. The dimensions of the goods placed on the pallet must not exceed the ground plan of the pallet and the height of 1900 mm at the most including the pallet.

Sterilization process of each of the chambers is independently computer-controlled. The parameters of the sterilization process are recorded and form an integral part of the sterilization report that is delivered to the customer together with respective tests.

Research and development

  • Products design
  • Prototype design
  • Prototype production, assembly, packaging
  • Pre – serial prdoduction – to serial production
  • Tube forming
  • Straightening, cutting
  • Chamfering
  • Grinding
  • Raughening (sand/laser)
  • Side hole grinding
  • Bending (tip, tube)
  • Electropilishing
  • 100% camera inspection
  • Injection/insert molding
  • Assembly (platic + metal componets)
  • ETO sterilization
  • Automatic packaing
  • Clean room production ISO 8/7
  • Accreditated laboratory

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