ULTRA-PACTOR®
Ultra-High Containment Production Roller Compactor — Gerteis
Overview
The ULTRA-PACTOR® pairs Gerteis’ proven PACTOR® roller compactor with a purpose-built integrated isolator, delivering ultra-high containment to OEB 5 (<0.1 µg/m³). Available on both the MINI-PACTOR® and MACRO-PACTOR® platforms, the ULTRA-PACTOR® configuration covers the full range from 10 g development trials through 400 kg/h production.
Unlike retrofitted containment solutions, the ULTRA-PACTOR®’s isolator was engineered as part of the machine from the ground up. A 350 mm Rapid Transfer Port allows convenient transfer of samples or parts without breaking containment. Split butterfly valve integration on feed and discharge provides fully contained connections to upstream and downstream equipment. Online pressure monitoring and monitored fire wall seals continuously track isolator integrity during operation.
Cleaning is fully automated. Integrated WIP/CIP runs within the containment envelope so operators never need to open the isolator for routine batch changeover. A push/push filter system enables safe-change filter swaps without compromising containment. The split HMI allows the operator interface to be placed outside the containment zone in the lab area.
The ULTRA-PACTOR® retains all of the core PACTOR® compaction features: free-floating gap design, perfect gap seal, oscillating mill, and full process instrumentation, with the containment envelope built around them. Mock-up tested handling procedures are validated with the customer prior to installation.
Key Specifications
| Throughput | 10 g per trial up to 400 kg/h |
| Press Force | 1–20 kN/cm |
| Roller Speed | 1–30 rpm |
| Gap | 1–6 mm |
| Weight | 2,300 kg |
| Containment | <0.1 µg/m³ (OEB 5) |
| Isolator | Custom Gerteis® design, integrated |
| Transfer Port | Rapid Transfer Port — 350 mm diameter |
| Controls | 21 CFR Part 11 compliant, split HMI |
Key Features
Purpose-Built Isolator
Custom Gerteis® isolator design achieves <0.1 µg/m³ (OEB 5). Online pressure monitoring and monitored fire wall seals provide continuous safety-critical integrity tracking during operation.
Rapid Transfer Port
350 mm diameter RTP allows convenient transfer of samples or parts in and out of the containment area during operation without compromising the containment envelope.
Split Butterfly Valve Integration
Feed and discharge points accept split butterfly valves (e.g., ChargePoint PharmaSafe) for fully contained connection to upstream and downstream equipment.
Fully Automated WIP/CIP
Wash-In-Place and Clean-In-Place are integrated into the containment envelope. Push/push filter system enables safe-change filter swaps without compromising containment.
Split HMI
The operator interface can be placed outside the containment zone, keeping the operator in the lab area while maintaining full process control.
Scalable Platform
Available on both the MINI-PACTOR® and MACRO-PACTOR® platforms. A single containment architecture covers the full range from 10 g development batches through 400 kg/h production.
Applications
- Highly potent API processing (HPAPIs) — oncology, hormonal, steroidal compounds
- Any compound requiring OEB 5 containment (<0.1 µg/m³)
- Contained line integration for HPAPI solid dose manufacturing
- Development through production on a single machine
- Multi-product CDMO facilities handling potent compounds
MHS Pharma — Northeast US Representative
MHS Pharma provides direct technical representation for Gerteis across the Northeast United States. Contact us to discuss the ULTRA-PACTOR® for your application.
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