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STERIFILL AMPOULES
Ampoule Filling & Sealing Machine

Small volume parenterals (SVP) can be packaged differently, based on their use: ampoules are chosen as the drug is in contact with glass only and as they are 100% tamper-proof. In turn, Sterifill Ampoules is chosen for the proper filling and sealing tools.

Small volume parenterals (SVP) can be packaged differently, based on their use: ampoules are chosen as the drug is in contact with glass only and as they are 100% tamper-proof. In turn, Sterifill Ampoules is chosen for the proper filling and sealing tools.

Preserving intactness

Liquid based injectable drug products require protection from microbial contamination and may also need to be protected from exposure to gases (e.g., oxygen), light, solvent loss, and so on.

For such reasons, when designing equipment intended for SVP primary packaging, accuracy and knowledge of the subject matter are imperative: STERIFILL AMPOULES incorporates both the cGMP guidelines and the FDA regulations, making it particularly fit for aseptic environments.

IMA Life
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IMA Life Pharmasiena

STERIFILL AMPOULES Highlights

1.
Narrow width allowing all main operations from operator side
2.
Left to right or right to left version available
3.
Easy integration with cRABS or Isolators (on demand)
4.
Dosing volume adjustable from HMI
5.
CIP/SIP module design as per IMA standard
6.
Trim collection from operator side or opposite operator side
7.
Statistical IPC available on all machine versions as well as for both ampoules and vials and reject station for incorrect vials (COMBI configuration)
8.
Compliance with 21CFR part 11 available on demand
With the Combi Version, the machine can alternatively process ampoules and vials. As the standard version, the Combi configuration features the same design construction and technical characteristics. The capping module is integrated with the transport system.
  • Technical Data
  • Machine Layout
TECHNICAL DATA STERIFILL AMPOULES
Model B4-6-8/A
Output (Ampoules)

Up to 12,000 ampoules/h. with 4 filling poumps

Up to 18,000 ampoules/h with 6 filling poumps

Up to 24,000 ampoules/h with 8 filling poumps

Ampoule size 1-25 mL
Vial size (for COMBI version) Ø 16 – Ø 30 mm
Weight 1,200 Kg – 1,500 Kg (COMBI)
Voltage 400 V – 50 Hz
Installed power 12 kW – 16 kW (COMBI)
STERIFILL AMPOULES Layout

STERIFILL AMPOULES Gallery

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Vial infeed and check
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Vial statistical check-weighing
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Vial stoppering area and outfeed
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Ampoule infeed and check
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Ampoule gas purging before filling
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Ampoule filling and gas purging
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Ampoule gas purging after filling
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Ampoule pre-heating station
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Ampoule pre-heating and sealing stations
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Ampoule sampling