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Beta Star cGMP/Pharmaceutical sterilizers are designed to help pharmaceutical customers meet the stringent compliance requirements of the FDA and move into production faster. From the moment they're installed, our sterilizers operate reliably, meet all FDA quality regulations and are 21 CFR Part 11 compliant.
Beta Star provides complete and in-depth documentation on every piece of equipment to ensure that it will validate smoothly and be up and running quickly.And once a Beta Star sterilizer is validated, it can be counted on to perform dependably with little downtime, minimizing costly interruptions to your process.
We offer a full line of sterilization products and processes including isothermal, saturated steam, air over-pressure, BL3/BL4 effluent, water cascade and steam/air mixtures.
Beta Star cGMP sterilizers are affordable and engineered for value so they won't break your budget. And they can be customized and delivered quickly to meet tight deadlines.
Features & Benefits
- 316L stainless steel chamber, jacket, & door constructed to ASME Section VIII, Division I pressure vessel code
- Mirror polished (<10Ra) chamber and door with "easy-clean" rounded corners and floor-sloping drain system
- Provided with Allen Bradley SLC 5/05 Programmable Logic Controller and PanelView touch screen operator interface in either 6" or 10" sizes
- Models available in automatic vertical sliding, automatic horizontal sliding, and hinged manual radial arm door. Each design includes software safety interlock and positive mechanical lock.
- 316L stainless steel sanitary piping for chamber process piping in orbital welded or triclamp connections. Welding documentation packages are available which include boroscope inspections recorded on video tape.
- High temperature FDA approved silicone door seal
- Non-proprietary components for all plumbing, electrical and control systems
- #4 polished, 16 gauge, 304 stainless steel fascia panels for recessed installation or free-standing cabinet
- Industrial grade pneumatic valves provide high reliability and low maintenance costs. Requires 80-100 air pressure.
- Integral quench system to reduce system discharge to <60 oC
- Each unit provided with both vacuum and gravity cycle capabilities for the sterilization of liquids, porous loads, and hard goods. Other processes can be provided and are in accordance with AAMI guidelines for Industrial Moist Heat Sterilization.
- Guaranteed chamber temperature control of +/- 0.5 oC
- Guaranteed chamber temperature distribution of +/- 0.5 oC
- Chamber drain line condensate level sensor system
- Ethernet communications for remote data acquisition capability
- Automatic temperature and pressure instrument calibration
- Manual over-ride of output devices for ease of verification and validation
- Warranty: 1 years chamber, 1 year parts and labor
Options
- Exclusive Beta Star Vac-U-Con high vacuum system
- Sterilizable-in-place insitu filter with independent sterilization cycle
- Loading equipment
- Clean steam generators (electric & steam to steam)
- Plant steam generators - electric
- Load probe for liquid cycles including Fo
- RO/DI high quality water systems
- Citric acid passivation according to ASTM A380
- Installation
- Validation services
- Bio-containment
Specifications (PDF format)
To view PDF files, you'll need Adobe® Acrobat™ Reader. Download here.
| 16" x 16" x 26" | Automatic Vertical Sliding |
Single Door Only |
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| 20" x 20" x 38" | Automatic Vertical Sliding |
Single & Double Door |
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| 26" x 26" x 39" | Automatic Vertical Sliding |
Single & Double Door |
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| 26" x 26" x 49" | Automatic Vertical Sliding |
Single & Double Door |
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| 26" x 26" x 51" | Automatic Vertical Sliding |
Single & Double Door |
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| 24" x 36" x 48" | Automatic Vertical Sliding |
Single & Double Door |
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| 24" x 36" x 36" | Manual Hinged Radial Arm |
Single & Double Door |
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| 24" x 36" x 48" | Manual Hinged Radial Arm |
Single & Double Door |
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| 24" x 36" x 60" | Manual Hinged Radial Arm |
Single & Double Door |
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| 26" x 36" x 48" | Automatic Horizontal Sliding |
Single & Double Door |
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| 26" x 36" x 60" | Automatic Horizontal Sliding |
Single & Double Door |
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| 26" x 48" x 76" | Automatic Horizontal Sliding |
Single & Double Door |
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| 26" x 63" x 76" | Automatic Horizontal Sliding |
Single & Double Door |
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| 35" x 57" x 49" | Automatic Horizontal Sliding |
Single & Double Door |
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| 35" x 57" x 60" | Automatic Horizontal Sliding |
Single & Double Door |
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| 35" x 57" x 72" | Automatic Horizontal Sliding |
Single & Double Door |
|
| 35" x 57" x 86" | Automatic Horizontal Sliding |
Single & Double Door |
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| 36" x 36" x 48" | Automatic Horizontal Sliding |
Single & Double Door |
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| 36" x 36" x 60" | Automatic Horizontal Sliding |
Single & Double Door |
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| 36" x 48" x 78" | Automatic Horizontal Sliding |
Single & Double Door |
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| 49" x 57" x 86" | Automatic Horizontal Sliding |
Single & Double Door |
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| 49" x 86" x 86" | Automatic Horizontal Sliding |
Single & Double Door |
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| 61" x 86" x 86" | Automatic Horizontal Sliding |
Single & Double Door |
cGMP Tech Sheet
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