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US-FDA approved & EN 27172 certified

VHP pass boxes, chambers and whole-facility decontamination.

Vaporised hydrogen peroxide that stays gaseous throughout the cycle, reaches the places aerosol methods cannot, and leaves zero residue — so the space is back in use the moment ppm returns to zero.

>6 log reductionUniform across the chamber
21 CFR Part 11 (optional)Full cycle data capture
Zero residueNo post-cycle cleaning
01Signtec Bio-Solutions

VHP Sterilization

GMP Cold Sterilization System

A patented VHP generator delivering superior vapour distribution and a uniform kill across the load. Built for heat-sensitive materials that cannot go through an autoclave.

Patented VHP generator Superior vapour Uniform >6 log reduction USFDA approved 21 CFR Part 11 compliant (optional)
Signtec VHP sterilization chamber, pass-through configurationVHP Sterilization
>6 logMicrobial reduction
ZeroResidue after cycle
USFDAApproved
EN 27172Certified
02The pass box range

Static and Dynamic VHP Pass Boxes.

VHP pass boxes move material between classified areas without opening a door between them, using vaporised hydrogen peroxide to decontaminate the surface of everything that passes through. Which one you need depends on whether the two areas share a cleanliness classification.

Static VHP Pass Box

Same or similar classification

For material transfer between areas of the same or similar cleanliness classification. It provides a controlled chamber for VHP decontamination before material moves into the receiving area.

Key features

  • VHP-based material surface decontamination
  • Interlocked doors to prevent simultaneous opening
  • Stainless steel construction for easy cleaning
  • Smooth, easy-to-clean internal surfaces
  • Automated VHP cycle control
  • Configurable cycle parameters
  • Integrated safety and alarm systems
  • Suitable for GMP and controlled manufacturing environments

Typical applications

Pharmaceutical manufacturingBiotechnology facilitiesCleanroomsSterile manufacturing areasResearch and laboratory facilities

Dynamic VHP Pass Box

Different classifications

Combines VHP decontamination with controlled airflow for an additional level of contamination control when transferring between areas of different cleanliness classifications.

The chamber holds a controlled airflow environment and incorporates filtration, so the risk of contamination during transfer is minimised rather than merely contained.

Key features

  • VHP-based decontamination system
  • Controlled airflow within the chamber
  • HEPA-filtered air supply and exhaust
  • Interlocked doors for controlled material transfer
  • Stainless steel internal and external construction
  • Automated VHP cycle and process monitoring
  • Differential pressure monitoring
  • Safety alarms and system interlocks
  • Designed for GMP and aseptic processing environments

Typical applications

Sterile pharmaceutical manufacturingAseptic processing areasBiotechnology and life sciencesCleanroom material transferHigh-containment environments

Why choose a VHP pass box?

It gives you a controlled and validated route for material transfer, reducing the risk of introducing viable and non-viable contamination into critical areas. Static or Dynamic is selected on facility layout, cleanliness classification, airflow requirements and the process itself — tell us those four and we will specify it.

03Sterilizer configurations

Sterilizer chamber configurations, and who uses them.

Choose a single-door chamber where material enters and leaves the same side, or a pass-through where the load moves between two classified areas without breaking the barrier.

Single door

Load and unload from one face. Suits standalone sterilization of heat-sensitive materials where the room classification does not change.

Pass-through

Doors on both faces with interlocking, moving material from a lower classification into a higher one with surface decontamination in between.

Pharmaceutical
Laboratories & research
Cosmetic
Medical devices
04Cleamix vH₂O₂ · Finland

Eight reasons vaporised H₂O₂ beats aerosol methods.

A high-performance vapour hydrogen peroxide decontamination and sterilization system for a fast process with zero residue, destroying pathogens hiding in inaccessible areas that aerosol-based methods cannot reach.

1

Gaseous process

Hydrogen peroxide is held in the gaseous phase throughout decontamination, so nothing is visible to the naked eye during the cycle.

2

Automated and flexible

Recipe programming for different scenarios — target ppm, treatment cycle duration and more — saved for reuse.

3

Shortest time

Every parameter including relative saturation is controlled, so the process runs faster. No residue means no post-cleaning, and the space is re-entered as soon as ppm reaches zero.

4

Compact and portable

The smallest Cleamix vH₂O₂ model weighs under 10 kg — the most compact on the market. A full AISI 304 enclosure is available as an option.

5

21 CFR compliant (optional)

Control system and software capture and record every process parameter through the cycle, with real-time data on the HMI to meet regulatory requirements.

6

BMS connectivity

Provision to connect to any BMS for data management and audit trail, with report generation for documentation.

7

Any volume of space

Models cover everything from a 1 m³ enclosure to spaces larger than 5000 m³.

8

Safe and convenient

A large wireless touchscreen tablet lets the operator run the process from outside the room, or remotely within WiFi range.

From 1 m³ to over 5000 m³

One technology, from a pass box to an entire facility.

The same Cleamix vH₂O₂ platform scales from a small enclosure through to a full cleanroom shutdown, with the smallest unit weighing under 10 kg and controlled from a wireless tablet outside the room.

Photo: Adam Bezer / Unsplash
05Pharmaceutical manufacturing

GMP H₂O₂ Sterilization Chambers

CLEA-C & CLEA-CP

The CLEA-C chamber handles surface bio-decontamination of pre-sterilized material packages before they move into a specific area. The CLEA-CP adds an optional particulate reduction system, making it a cleanroom-compatible route for heat-sensitive materials in aseptic manufacturing.

Typical loads include vial stopper bags, wrapped components, syringes and other sterile-packed raw materials.

  • Cleamix (Finland) non-condensing vaporised hydrogen peroxide technology giving 6-log reduction of bioburden.
  • Unique process for reducing bio-particulates on transferred materials.
  • Short cycle time with proven bio-decontamination results throughout the chamber.
  • Completely independent system, straightforward to install and validate.
  • Enables 21 CFR Part 11 compliance (optional).
  • Automated, controlled process environment.
  • No toxic process by-products.
  • Excellent material compatibility.
CLEA-C GMP H2O2 sterilization chamber with CleamixCLEA-C / CLEA-CP
6 logMicrobial kill in chamber
>0.3 µmParticle detection
HEPAIntegrity monitored on-line
IQ / OQFactory tested pre-shipment

The particulate monitor sits in the duct above the HEPA filter. Load and chamber are flushed with HEPA-filtered air until the pre-programmed cleanliness level is reached, and an alarm triggers if particles above 0.3 µm pass the filter.

NVAK engineer running a Cleamix vH2O2 decontamination cycleCleamix VCS on site
Professional service

vH₂O₂ decontamination, scheduled or on call.

From a single piece of equipment or a small chamber through to entire facilities, using the Cleamix Oy (Finland) system. Arranged as contamination response or as preventive control, in line with your environmental monitoring data, scheduled maintenance and shutdown periods.

Flexible packages

  • Annual, half-yearly, quarterly and monthly plans
  • On-call decontamination plans
  • Decontamination validation packages
  • Equipment packages for biosafety cabinets, isolators and containment equipment

Trained engineers

  • Trained in safety protocols during decontamination
  • Trained on the equipment itself
  • Experienced across different room types and environments

Validation documentation

  • 21 CFR compliant (optional) automated system-generated report
  • Chemical indicator validation document
  • Supplied after every decontamination

Turnkey process

  • Any volume of space, from a chamber to a whole facility
  • Closed enclosures and equipment
  • Complete turnkey delivery
06Client feedback

What the institutions told us afterwards.

Written feedback from research institutes, universities, hospitals and diagnostic centres following vH2O2 bio-decontamination carried out by our team. Tap any letter to read it in full.

Personal email addresses and direct phone numbers have been redacted from these documents. Originals are available on request.

07Compliance

Standards applied in design, manufacture and testing.

The bio-decontamination chamber is designed, manufactured and tested against the following. Complete IQ/OQ testing is carried out at the factory test area before shipment.

  • Machinery Directive 2006/42/EC
  • Low Voltage Directive 2014/35/EU
  • Electromagnetic Compatibility (EMC) 2014/30/EU
  • EN 60204-1 and IEC 60204-1
US-FDA approvedEN 27172 certified 21 CFR Part 11 (optional)No toxic by-products
2006/42/ECMachinery Directive
2014/35/EULow Voltage Directive
2014/30/EUEMC Directive
60204-1EN and IEC

Hydrogen peroxide vapour is hazardous during a cycle. Systems are supplied with interlocks, ppm monitoring and remote control so the operator stays outside the treated space until the reading returns to a safe level.

Tell us the volume and the load.

Chamber size, material type, room classification and cycle frequency are what we need to scope a VHP system or a decontamination contract. Send those and we will come back with a specification and a price.

Related lines

Also supplied by NVAK
  • Esco Life Sciences — biosafety cabinets, isolators, incubators, ULT freezers and more.
  • Sterizen UV Disinfection — UV-C surface and air disinfection systems.
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