How to Contain a Roller Compactor: A Practical Guide from OEB 3 to OEB 5
Gerteis PACTOR plus ChargePoint PharmaSafe split butterfly valves — matched containment tiers from standard dry granulation through HPAPI.
How Do You Contain a Roller Compactor?
Short answer: with a Gerteis PACTOR matched to your compound’s OEB tier, and ChargePoint PharmaSafe split butterfly valves at the feed and discharge.
The compactor changes with potency. At OEB 3 it’s a standard machine. At OEB 4 it’s a machine with Gerteis’ Advanced OEL Design, or the Macro-Pactor C containment variant. At OEB 5 it’s the Ultra-Pactor, with a purpose-built integrated isolator. What doesn’t change is the transfer technology — ChargePoint split butterfly valves are the common thread at every tier, because that’s where the airborne exposure actually happens on a roller compaction line.
This is a practical guide to matching the two sides together — the compactor tier to your compound, the valve tier to your containment target — from standard dry granulation through HPAPI manufacturing.
The Compactor: Gerteis PACTOR Platform
The PACTOR is closed by design: powder enters through a feed hopper, gets pressed between two rolls, and exits as ribbon that is immediately milled into granules. The two moments where airborne particulate is actively generated — the feed and the oscillating mill at the discharge — are the only transfer points that have to be contained externally. Every PACTOR ships with tri-clamp connections at both, ready to accept a ChargePoint split butterfly valve.
Mini-Pactor — Development and Small-Scale Production
Lab and pilot machine. Runs trials with as little as 10 g and scales up to 100 kg/h. Critical for potent compounds because early development batches are often milligram quantities of precious API.
- Standard OEL < 3 μg/m³ out of the box (OEB 3)
- Advanced OEL Design < 1 μg/m³ (OEB 4) as a factory option
- Split-valve-ready feed and discharge; WIP/CIP available
Macro-Pactor — Clinical and Commercial Production
Production sibling, 100 g trial quantities up to 400 kg/h. Shares identical roll geometry, press force, gap, and speed with the Mini-Pactor — process parameters developed in the lab transfer directly with a roughly 4× throughput increase from the wider 10 cm rolls.
- Macro-Pactor (standard) — OEL < 3 μg/m³, with optional Advanced OEL Design down to < 1 μg/m³
- Macro-Pactor C (containment variant) — OEB 4 as standard (< 1 μg/m³), with a through-the-wall mount option. Feed and discharge designed for integration with high-OEB split valves.
Ultra-Pactor — HPAPI Production with Integrated Isolator
Gerteis’ ultra-high-containment production machine. Throughput up to 400 kg/h with a 10 g trial minimum, same scale-up story as the Macro-Pactor — but with a purpose-built Gerteis isolator engineered around the compactor from the ground up.
- Containment < 0.1 μg/m³ (OEB 5)
- Fully automated WIP/CIP inside the containment envelope
- Rapid transfer port (Ø 350 mm) for samples and parts
- Split HMI — operator interface outside the containment zone
- Monitored fire-wall seals and online pressure monitoring
- Push/push safe-change filter system
- Split butterfly valve integration on feed and discharge (ChargePoint PharmaSafe / PharmaSafe Pro)
The Transfer Valves: ChargePoint PharmaSafe
The split butterfly valve is the technology that closes the transfer points on a roller compaction line at every tier — from a standard OEB 3 line up to the Ultra-Pactor’s OEB 5 installation. A single butterfly disc is split into two halves: the active (alpha) mounts permanently to the compactor port, the passive (beta) travels with the powder container. Neither opens independently. Only when docked do the disc halves combine into a single sealed butterfly that can rotate open for transfer. When undocked, product-contact faces are sealed back inside their housings — no open powder at any point.
PharmaSafe (Standard) — Down to 1 μg/m³
Achieves OEB 4 containment through the split valve geometry alone, no extraction required. DN50 (2″) through DN250 (10″), pressure-rated to 6 bar (10 bar optional), manual, semi-automatic, or fully automatic. Paired with a standard or Advanced-OEL PACTOR, or a Macro-Pactor C, the standard PharmaSafe on feed and discharge is a complete containment solution for OEB 3 and OEB 4 compounds.
PharmaSafe Pro + Extraction Skid — Down to 0.1 μg/m³
At OEB 5, the containment ceiling of a split butterfly valve alone is set by what the industry literature calls the “ring of concern” — the narrow annular region where the two disc halves meet. For OEB 4 that’s within the limit; for sub-microgram OEB 5 it has to be actively managed. The Pro valve adds an extraction port on the outer body, and the Extraction Skid — a compact, fully pneumatic HEPA unit — connects via a 4 m hose and draws low-volume air through the valve interface during and after docking. Any residual particulate is captured before it can become airborne.
- Dual H14 HEPA filters (EN1822) with independent differential pressure gauges
- Minimum 1,300 l/min extraction rate through the valve interface
- Fully pneumatic — no electrical supply, compressed air at 6 bar. ATEX version available.
- Safe-change filter bag-out port
- Wall-mounted (40 kg), floor-standing (62 kg), or mobile on castors (62 kg)
The Pro valve with the Extraction Skid is the transfer technology specified on the Ultra-Pactor for OEB 5 operation — the same ChargePoint split butterfly valve principle used at OEB 3 and OEB 4, upgraded with active extraction to manage the ring of concern at sub-microgram levels.
Matched Across Tiers
Both Gerteis and ChargePoint build tiered containment mapped to the same OEL breakpoints. That eliminates the single most common failure mode in containment specification: matched headline numbers on individual components, mismatched containment at the interfaces between them.
| Containment Target | Compactor | Transfer Valves | Extraction |
|---|---|---|---|
| < 3 μg/m³ (OEB 3) | Mini-Pactor / Macro-Pactor (standard) | PharmaSafe (standard) | Not required |
| < 1 μg/m³ (OEB 4) | Mini/Macro-Pactor with Advanced OEL, or Macro-Pactor C | PharmaSafe (standard) | Not required |
| < 0.1 μg/m³ (OEB 5) | Ultra-Pactor (integrated isolator) | PharmaSafe Pro | PharmaSafe Extraction Skid |
Specifying a Contained Dry Granulation Line?
MHS Pharma represents both Gerteis and ChargePoint Technology across North America. Whether you’re moving a potent compound from Mini-Pactor development into Macro-Pactor or Ultra-Pactor production, or retrofitting contained transfer valves onto an existing compactor, we can help you match the right equipment tier to your compound’s OEL.
Talk to MHS