When can the clean side door be opened?

Electromagnetic door locks release only when the internal H2O2 sensor verifies residual gas is below 0.5 ppm.

What drainage is required at the installation point?

A floor drain sized for the peak discharge rate is required adjacent to the machine, with an air break to prevent back-siphonage. The utility schedule supplied with the machine gives the exact flow and connection sizes.

What warranty applies to this machine?

Machines are supplied with a 12-month warranty from commissioning covering manufacturing defects, with wear parts and tooling excluded. Extended cover is available under an annual maintenance contract, which also fixes response times for breakdown attendance.

What documentation is supplied at handover?

Handover includes the operation and maintenance manual, electrical and pneumatic schematics, the spare parts list with part numbers, material test certificates for contact parts, sensor calibration certificates and the completed qualification dossier.

What water quality does the machine require?

Final rinse requires Water for Injection or Purified Water depending on the dosage form, supplied at the specified pressure and temperature. Earlier rinse stages can run on potable or purified water, and the machine records the conductivity of the final rinse.

How is cleaning effectiveness demonstrated?

Effectiveness is demonstrated during performance qualification by riboflavin coverage testing, followed by swab and rinse sampling against the residue limit calculated for your worst-case product.

CST-100 Cleanroom Sterile Pass-Through Transfer Box with VHP

Name: CST-100 Cleanroom Sterile Pass-Through Transfer Box with VHP
Brand: GentlemanPharmed
Availability: InStock

Dynamic bio-decontamination pass box with integrated Vaporized Hydrogen Peroxide (VHP) generator and HEPA laminar flow for Grade A cleanroom material transfer.

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Overview

About the CST-100 Cleanroom Sterile Pass-Through Transfer Box with VHP

The **CST-100 VHP Pass Box** enables rapid, validated 6-log bio-decontamination of materials transferred between Grade B cleanroom preparation areas and Grade A aseptic filling suites. Incorporating an on-board flash vaporizer VHP generator and catalytic aeration filters, complete surface sterilization cycles are executed in under 25 minutes.

Integrated Flash Vaporizer VHP Generator: Generates dry hydrogen peroxide vapor ensuring zero droplet condensation on sensitive material packaging.

Recorded Final Rinse Conductivity: Final rinse water quality is measured and written to the batch record, giving objective evidence that the cleaning cycle completed to specification.

Validated Cycle Recipes: Wash, rinse and dry stages run to stored recipes, so the qualified cycle is reproduced exactly on every load.

Specifications

Technical Specifications

Technical specifications for the CST-100 Cleanroom Sterile Pass-Through Transfer Box with VHP
Internal Dimensions	800 mm (W) × 800 mm (H) × 800 mm (D)
Bio-decontamination	6-Log sporicidal reduction
Air Cleanliness	ISO Class 5 (Grade A Laminar)

* Specifications may vary by model. Contact us for exact configuration.

Validation Support

Full IQ/OQ/PQ documentation packages available. Our validation team works with your QA department to ensure regulatory acceptance.

Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Factory Acceptance Test (FAT)
Site Acceptance Test (SAT)

Compliance Standards

Built and tested to international pharmaceutical manufacturing standards.

WHO-GMPISO 9001CE MarkedCDSCO

FAQ

Product FAQs

Common questions about our pharmaceutical machinery.

CST-100 Cleanroom Sterile Pass-Through Transfer Box with VHP — Product Brochure

Technical specs, dimensions & ordering guide · PDF

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About the CST-100 Cleanroom Sterile Pass-Through Transfer Box with VHP

Internal Dimensions

800 mm (W) × 800 mm (H) × 800 mm (D)

Bio-decontamination

6-Log sporicidal reduction

Air Cleanliness

ISO Class 5 (Grade A Laminar)