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Overview

ChargePoint AseptiSafe aseptic transfer valve

AseptiSafe is ChargePoint’s aseptic transfer valve range, using patented split-valve technology for sterile and high-containment powder and component transfers. The valve divides into an active half mounted to the process vessel or filling line and a passive half on the mobile container. Neither half can open until the two are docked, and when they dock the disc halves lock into a single sealed unit, so only previously sealed surfaces are ever exposed to the product path.

The range comes in two variants built on the same docking principle. AseptiSafe is sterilized by autoclave, gamma, or steam-in-place for use in high-grade cleanrooms. AseptiSafe bio adds a vaporized hydrogen peroxide (VHP) decontamination step between the docked halves, which lets lower-grade areas run aseptic transfers without upgrading the room. Where PharmaSafe is built for containment of the operator from the product, AseptiSafe is built to protect the product from contamination.

Containment independently validated per ISPE SMEPAC guidelines. AseptiSafe bio achieves a validated 6-log biological reduction across the critical mating faces.

Valve Specifications

Valve sizesDN50 (2″) to DN200 (8″)
SIP ratingUp to 2.5 bar (36 PSI)
Pressure ratingUp to 6 bar (87 PSI) on DN50 and DN100, up to 3.5 bar (50 PSI) on DN150 and DN200
Vacuum ratingFull vacuum
OperationManual, semi-automatic, or fully automatic
Body material316L stainless steel, product contact parts passivated
SealsEPDM, FKM, or FFKM (process-dependent)
ConnectionsTri-Clamp (BS/ISO/DIN/JIS), Aseptic Tri-Clamp (ASME BPE), or custom
ValidationISPE SMEPAC, independently validated

Two Variants

AseptiSafeSterilized by autoclave, gamma, or steam-in-place. Suited to Grade A/B (ISO 5) high-grade cleanroom areas. Available across all sizes from DN50 to DN200.
AseptiSafe bioFloods a sealed chamber between the docked halves with vaporized hydrogen peroxide before the disc opens, achieving a validated 6-log reduction. Suited to Grade D (ISO 8) low-grade areas. Available in DN50 and DN100.
Without extraction<10 µg/m³ (OEB 4)
With extraction<1 µg/m³ (OEB 5)

Key Features

Validated 6-Log Reduction

AseptiSafe bio floods the docked interface with vaporized hydrogen peroxide before the valve opens, decontaminating all critical mating faces to a validated 6-log biological reduction.

Aseptic Transfer in Lower Grade Areas

Because sterility is maintained inside the valve, AseptiSafe bio allows aseptic transfers in Grade C and D areas without upgrading the surrounding cleanroom.

Multiple Transfers Without Re-Sterilization

The valve holds its sterile barrier across repeated docking cycles, so a line can run multiple transfers without a steam-in-place step between each one.

Mechanical Safety Interlocks

The valve cannot open unless the active and passive halves are correctly docked, so only previously sealed and clean interfaces are ever exposed to the product.

VERIFi Wireless Monitoring

Optional VERIFi wireless monitoring captures equipment usage data and an audit trail, supporting proactive maintenance across the valve fleet.

Single-Use Transfer Path

Paired with ChargeBag and a Single Use Passive valve, the system removes rigid container cleaning and multi-step sterilization from the transfer.

Applications

  • Powder filling and dispensing: API charging into mixing vessels, IBCs, and filling lines
  • Component handling: stoppers, caps, and closures transferred to fill and finish lines
  • Aseptic processing: sterile API dispensing within isolators or RABS
  • Buffer and media preparation: powder transfer to formulation and mixing tanks
  • Bulk powder discharge from process vessels
  • Batch gamma irradiation: components loaded into ChargeBag, sterilized off-site, then transferred

MHS Pharma — Northeast US Representative

MHS Pharma provides direct technical representation for ChargePoint Technology across the Northeast United States. Contact us to discuss aseptic and contained powder transfer for your sterile process points.

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