VHP-Compatible Pass Box

What is the VHP-Compatible Pass Box?

A VHP-compatible pass box has sealed construction and ports for hydrogen peroxide vapour decontamination of the chamber. It is used in aseptic and isolator-linked processes that require validated bio-decontamination of transferred items.

Overview

The chamber is welded 316L stainless steel with continuous seams and inflatable or compression gaskets on doors, tested for leak tightness, for example a pressure decay below 1 % in 30 minutes at 250 Pa. Inlet and outlet ports connect to an external VHP generator, which injects vapour at typically 1–5 g/min until concentrations of 300–1000 ppm are reached, followed by aeration to below 1 ppm. Catalytic converters may be built in. Interlocks prevent door opening during the cycle and connect to the generator controller. Internal sizes range from 500 × 500 × 500 mm to 1000 × 800 × 800 mm. Materials are chosen for hydrogen peroxide compatibility.

How does it work?

A pass box is a stainless steel or powder-coated steel chamber with two doors, one facing each side of the wall. Mechanical, electromagnetic or electronic interlocks ensure that only one door can open at a time, so the two areas are never directly connected. Static versions rely on this interlock alone, with smooth surfaces and coved corners that can be wiped down. Dynamic versions add a fan, prefilter and HEPA filter that flush the chamber with clean air, typically at 0.3–0.5 m/s. Some versions include UV-C lamps at 254 nm to reduce surface microbes, or VHP-compatible seals for decontamination. Viewing windows of tempered glass, indicator lamps and door-status controls help operators. Wall-mounting frames must be sealed to the partition to maintain room pressure cascades.

What are the key features?

• Welded 316L chamber with continuous seams
• Inflatable or compression door gaskets
• Inlet and outlet ports for VHP generator
• Leak-tight design with pressure decay test
• Interlocks linked to decontamination cycle
• Optional catalytic converter for exhaust

What are the technical specifications?

A typical vhp-compatible pass box configuration offers chamber material of 316L stainless steel, welded, internal size of 500 × 500 × 500 to 1000 × 800 × 800 mm, leak rate of ≤ 1 % pressure decay in 30 min at 250 Pa, VHP concentration of 300–1000 ppm, aeration target of < 1 ppm H2O2 and door seal of Inflatable or compression gasket. Values are indicative of the product class; the exact figures for each configuration are confirmed on the quotation and the calibration documents supplied with the instrument.

Which applications is it used for?

The VHP-Compatible Pass Box is used in aseptic filling lines, isolator transfer, cell therapy manufacturing and sterility test suites. Across the wider Pass Boxes class, laboratories also deploy it for pharmaceutical material transfer, sterile manufacturing and hospital pharmacies.

Which standards and certifications apply?

Relevant standards and methods include ISO 14644-1 (cleanroom classification), ISO 14644-4 (design and construction), EU GMP Annex 1 (sterile manufacturing), GB 50073 (cleanroom design code), JG/T 382 and EN 1822 (HEPA and ULPA filters). Certification candidates for this model are CE and ISO 9001 manufacturing; each is to be confirmed for the specific configuration before shipment, and certificates are supplied only where they have been issued.

Install the pass box during wall construction or in a prepared opening, sealing the flange with silicone or gaskets so pressure differentials are maintained. Interlock function and emergency release should be tested at commissioning. Clean chambers before and after each use with compatible disinfectants, avoiding chlorides on stainless steel. UV lamps lose output after about 8000 hours and should be replaced and measured with a UV meter. Dynamic boxes require prefilter replacement every 3–6 months and HEPA integrity testing annually. Define SOPs for which items may be transferred and how long doors may remain open, and document cleaning for GMP audits.

How do I select the right VHP-Compatible Pass Box?

Choose a VHP-compatible box for Grade A or B aseptic operations or isolator interfaces that need a validated cycle. It needs a VHP generator and cycle development. RFQ: chamber size, port type, leak requirement, control interface and validation documentation.

How does it compare with other Pass Boxes variants?

Decide first whether a static, dynamic or decontamination-capable box is needed. Static boxes suit transfers between rooms of similar class, while dynamic boxes suit a step of at least one ISO class, for example ISO 8 to ISO 7. Check chamber size against the largest item, with common clear sizes from 400 × 400 × 400 mm to 800 × 800 × 800 mm, and the wall thickness, which is 50–100 mm for panels. Select the interlock type, mechanical for cost, electromagnetic or electronic for control and alarms. Consider UV, VHP or bio-decontamination requirements, housing material, and whether the chamber needs a floor-standing roller conveyor. Confirm the electrical and control interface.