STERIPAK HOT AIR LAMINAR FLOW STERILISING TUNNELS
The use of STERIPAK Hot Air Laminar Flow Sterilizing Tunnel enables integration of the process of Sterilization and Depyrogenation of washed empty glass containers for parenteral products with aseptic, continuous, automatic filling in which all steps are performed under better than ISO 5 (Class 100) conditions.
In this tunnel, vials and ampoules are transported by a stainless steel wire loop conveyor through Drying, Sterilizing, Cooling and Stabilizing zones under sub-turbulent ISO 5 (Class 100) "first air". The sterile receptacles are then unloaded directly into the sterile area. This process eliminates intermediate material handling and the potential for product contamination during those steps no longer exists.
Backed up by our expert team to help you demonstrate that Sterilization and Depyrogenation cycle consistently produce sterile and pyrogen free products, our system represents several innovative steps forward in the design and construction of a reliable, easy to operate, cost-effective depyrogenation tunnel.
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Highlights
n State-of-the-art ergonomics satisfying the IQ and OQ requirements of the user.n Uniformity of air flow pattern in Sterilization zone by picking up air from both sides under the conveyor for recirculation.n Stable hot zone temperature uniformity of + 5 degC maintained at 350 degC.n Linearized cooling rates with common source air.n More convenient HEPA filter access and general serviceability. All filters accessible for DOP leak test by scanning.n Temperature profile verification and facility (optional) to interface or network into host computer systems.n Sophisticated controls to maintain/monitor air flow, relative pressures, belt speed and other parameters.n Good pressure balance between sterile and non sterile sides to avoid high drafts or reverse flow into sterile environment.
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Model |
Overall dimensions (mm) |
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Length |
Width |
Height |
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A450 H1C3 |
3735 |
1015 |
2340 |
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V600 H2C3 |
3960 |
1220 |
2340 |
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V900 H2C3 |
3960 |
1525 |
2340 |
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V600 H3C3 |
3962 |
1219 |
2340 |
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V900 H3C3 |
4443 |
1675 |
2340 |
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Tech-brief |
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Governing standards |
ISO 14644 (1998) |
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Air velocity |
90 fpm (0.45 mps) +/- 20% in all zones except sterilisation, where it is maintained in the range 130 - 160 fpm (0.65 - 0.80 mps) |
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Cleanliness level |
Fewer than 100 particles of size 0.5 m or larger per cu.ft of air sampled ( or < 3,520/cuM ) |
| Tunnel Integrated with PETALS Ampoule washing Machine. |
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