Tailin Sterile Transfer Passageway(aseptic production)0 pages

Sterile Transfer Passageway

♦ technical parameters

Chamber Material: SUS 304 stainless steel

Note: If using SUS316 material, it is better to be specified in the

contract

HEPA filter levels: air supply HEPA: H14 level, air exhaust HEPA: H14-

level

Alarm: High / low pressure alarm; when door opening time is timeout:

lock alarm

Biological decontamination cycle time: < 120min

Note: It is according to the material bioburden levels and load mode.

Biological decontamination effectiveness: lg6 (Bacillus

stearothermophilus, ATCC12980 or ATCC 7953)

VHPS residue levels: < lppm

Note: Residue levels are determined by the technical requirements.

Cabin cleanliness (particle level): Class B

Hydrogen peroxide decontamination cycle interfaces: DN32 aseptic

interface

Exhaust Interface: DN100 aseptic interface

It can save and print biological decontamination cycle parameter data

C 0 »-r-

♦Product Dimensions

SteriTransfer™Sterile Transfer Passageway is

used to biologically decontaminate the outer surface

of the materials, which in order to prevent the

pollution brought by materials that transferring from

non-level region or low4evel clean areas into Class A

/ B critical area. This product is suitable for all kinds

of aseptic and dry goods need to be passed during

aseptic production, such as outer packing ,

equipment, raw materials' packaging, accessories,

environmental monitoring equipments, etc.

Note: Other sizes are customized according to your requirements.

♦ Features

SteriTransfer™Sterile Transfer Passageway using hydrogen

peroxide vapor (VHPS) as a biological detergent, which

operating under low temperature, atmospheric conditions, is

efficient and environmental-friendly. Hydrogen peroxide

sterilization method is also collected in the Pharmacopoeia of

United States, China and other countries;

SteriTransfer™Sterile Transfer Passageway is controlled by a

SIEMENS programmable logic controller (PLC). The system is

stable and reliable;

The air put into the cabin in the biological decontamination and

exhaust phase has filtered by H14 class HEPA filters, which in

order to keep materials free from pollution;

SteriTransfer™Sterile Transfer Passageway has a separate

ventilation unit, including fans, pneumatic valve and ventilation

exhaust line, which enables the hydrogen peroxide gas in the

cabin change quickly and prevents the gas from entering the

HAVC system;

Double swing doors with pneumatic seals, pneumatic locking

and two-door interlock in the working status;

SteriTransfer™Sterile Transfer Passageway interior are

designed with transportable material supports and track

system, which make it convenient to load and unload

materials;

The system is capable of monitoring the cabin temperature,

humidity and pressure in real-time, and hydrogen peroxide

concentration, planktonic bacteria dust particles and

detection ports is optional;

SteriTransfer™Sterile Transfer Passageway with complete

IQ, OQ and PQ documents, is easy to verify and can provide

on-site verification.