Truking Aseptic Filling, Freeze Drying and Isolator Equipment

Truking Technology Limited is a pharmaceutical equipment manufacturer from Changsha, China, founded in 2000: ampoule and vial lines, Flextron nest fillers, BFS machines, Lyotk freeze dryers, isolators and inspection machines.

Ampoule washing, filling and sealing lines

The Truking ampoule line combines a vertical ultrasonic washer, a sterilizing and depyrogenation tunnel and a servo-driven filling and sealing machine with a walking beam. Dosing accuracy is ±0.5–1%, and inert gas purging before and after filling keeps oxygen residue below 1%.

  • Dosing accuracy ±0.5–1%
  • Oxygen residue below 1%
  • Servo drive and walking beam
  • SS316L contact parts

Vial filling, stoppering and capping

Truking servo-driven vial filling and stoppering machines run up to 24,000 vials per hour in sizes of 2–100 ml with dosing accuracy of ±0.5–1%. For oxygen sensitive products, headspace oxygen is reduced to 0.5%. ZG series machines crimp aluminium caps at up to 36,000 vials per hour.

  • Up to 24,000 vials per hour
  • Vial sizes 2–100 ml
  • Headspace oxygen 0.5%
  • ZG capping: 36,000 per hour

Flextron nest fillers for syringes

The Flextron series fills ready-to-use vials, prefilled syringes and cartridges from nests on one machine at up to 36,000 units per hour. For syringes Truking builds the PPL12: together with the PSHK300 de-nesting machine it inserts plunger rods and applies labels at over 200 syringes per minute.

  • Up to 36,000 units per hour
  • Vials, syringes, cartridges
  • PPL12: over 200 per minute
  • PSHK300 de-nesting machine

Blow-fill-seal BFS machines

The Truking BFS machine forms, fills and seals plastic ampoules under aseptic conditions. Container sizes range from 0.5 ml to 1 l, with a rated output of 24,000 units per hour for 2 ml. Extrusion holds wall thickness within ±0.02 mm, and the dosing system uses 30% less energy.

  • Containers 0.5 ml to 1 l
  • 24,000 per hour at 2 ml
  • Wall thickness ±0.02 mm
  • 30% less dosing energy

Lyotk freeze dryers and loading systems

In Lyotk industrial freeze dryers the chamber and condenser are fabricated at one time, shelves are made by vacuum brazing, and the chamber to shelf area ratio is 1:1. The door seals with an inflatable gasket. The mobile RGV loading and unloading system transfers up to 1,000 vials per minute.

  • Vacuum brazed shelves
  • Chamber to shelf ratio 1:1
  • Inflatable door gasket
  • RGV: 1,000 vials per minute

LVP lines for soft bags and glass bottles

The non-PVC soft bag line produces infusion bags of 50–3000 ml and fills them using mass flow meters. For glass infusion bottles Truking builds vertical fine washing machines for 30–1000 ml with a separate WFI rinsing station.

  • Soft bags 50–3000 ml
  • Non-PVC film
  • Mass flow meter filling
  • Bottles 30–1000 ml

Isolators and barrier systems

Truking isolators serve aseptic filling and handling of toxic APIs: a 3 mm SUS316L stainless steel chamber, 15 mm tempered glass windows, ISO 4.8 cleanliness and hydrogen peroxide vapour sterilization. The leak rate is tested online to ISO 10648, and gloves with a leak detector down to 100 μm.

  • SUS316L chamber, 3 mm
  • 15 mm tempered glass
  • Cleanliness ISO 4.8
  • Glove leak test 100 μm

Inspection and leak testing machines

Truking automatic visual inspection machines view ampoules and vials through 360° and detect particles from 40 μm per pharmacopeia. High voltage leak testing finds micro pores down to 0.2 μm without opening the container. X-ray machines inspect powder and freeze dried vials for foreign particles.

  • Particles from 40 μm
  • 360° container view
  • Micro pores to 0.2 μm
  • X-ray particle check

Selecting a Truking line by container type

A line is chosen by the primary container and the required output. Ampoules are handled by a washer, a sterilizing tunnel and a filling and sealing machine with dosing accuracy of ±0.5–1%.

Vials of 2–100 ml are filled and stoppered at up to 24,000 units per hour, and ready-to-use syringes and cartridges by Flextron nest fillers at up to 36,000 units per hour.

Plastic ampoules from 0.5 ml to 1 l are produced on BFS machines, and infusion solutions on soft bag lines for 50–3000 ml and glass bottle lines for 30–1000 ml.

Freeze drying, isolation and pure steam

For lyophilized products, vial lines are combined with Lyotk freeze dryers and mobile RGV loading at up to 1,000 vials per minute. Toxic APIs are handled in SUS316L isolators with ISO 4.8 cleanliness and hydrogen peroxide sterilization.

The plant also includes pure steam generators with online pressure adjustment of 2–5 bar and a start from standby in less than 30 seconds, plus inspection machines detecting particles from 40 μm and leaks down to 0.2 μm.

Industrial equipment

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