VHP

一、Introduction

VHP PASS BOX is designed for VHP VHP PASS BOX of materials during transfer from an area of lower classification to an area of a higher classification. The Unit is especially suitable for GMP regulated pharmaceutical companies manufacturing drugs aseptically.

二、STANDARDS 

Products are designed and manufactured to meet CE mark and

applicable sections of the following European Union directives:

• Machinery Directive 2006/42/EC

• Low Voltage Directive 2014/35/EU

• Electromagnetic Compatibility (EMC) 2014/30/EU

Common standards used during the design, manufacturing and

testing of the VHP PASS BOX chamber is as follows:

• EN 60204-1

• IEC 60204-1

三、DESCRIPTION

VHP PASS BOX is surface VHP PASS BOX of pre-sterilized material packages, such as vial stopper bags,  Wrapped components and syringes. Vaporized H2O2 technology that ensures 6 - log reduction of bioburden  Unique process for reducing particulates on transferred materials Short cycle time with proven VHP PASS BOX result throughout chamber Completely independent system that is easy to install and validate 21 CRF 21 Part 11 compatibility Automated controlled process environment No toxic process by-products Excellent material compatibility Maximized throughput in pre-designed high quality cartone-steel chamber Feasibility testing and full load Cycle development tests with Customer product loads available as an option Complete IQ/OQ testing of equipment at factory testing area prior to shipment Factory Acceptance Test (FAT) in the state of art testing facility at the factory.

develops,  documents and enforces policies and procedures ensuring the security of electronic records and signatures according to  21 CFR Part 11. Together with our Customers,  involving validation: helps and enforce Part 11- compliant solutions; audit trails and security of our computer systems. For VHP  PASS BOX, CFR 21 Part 11 option is available. With this option,  system includes electronic records, electronic signatures,  PDF electronic batch reports and audit trails. provides more details as requested.

四、FEATURES

VHP PASS BOX  of materials prior to transfer from an area of lower classification to an area of a higher classification. The system is developed, manufactured and tested with the following features:

Public works of this as follows:

五、CYCLE DESCRIPTION

Sterilizer VHP PASS BOX Cycle consists of three phases:

1.  Work area humidity, pressure difference adjustment

2.  VHP  injection concentration control

3.  VHP residue treatment after sterilization

Before processing

removes excess moisture and reduces particles from chamber and load. Pre-conditioning is essential to reduce chamber humidity to enable a successful H2O2 biodecontaminant exposure phase. Too high humidity in chamber leads to low concentration of H2O2 vapor and suboptimal

VHP PASS BOX.

    Both chamber and load are flushed with an air flow created by an internal fan during pre-conditioning. The powerful fan  located above chamber false ceiling creates a highly turbulent air flow that effectively loosens particulates off load  And conducts them to H14 HEPA filter. At the same time, high air flow my dryer rapidly removes chamber moisture.

VHP  injection concentration control

VHP PASS BOX Phase consists of two distinctive steps:

1. Conditioning Step where VHP sterilant concentration is brought to desired level(For example, 300ppm).

2. VHP Step where desired sterilant vapor concentration is maintained for a

required period of time

CONDITIONING Step

H2O2 sterilant vapor from a vaporizer is circulated inside chamber by a fan. Vaporizer flash vaporizes aqueous H2O2 solution and disperses it to airstream in a controlled manner. This step is used to increase concentration inside enclosure as quickly as possible to a level slightly below point of

saturation. Concentration is gradually increased inside

chamber until correct level has been reached.

EXPOSURE Step

Exposure VHP PASS BOX step begins when optimal H2O2 sterilant concentration inside chamber has been reached. Exposure step holds a concentration inside enclosure just under saturation point until desired level of bioburden reduction has been achieved. H2O2 injection rate depends on load configuration, temperature, materials and chamber size. Exact exposure

time depends also on load qualities such as material and packing density and needs to be validated for each load type separately

VHP residue treatment after sterilization

During this phase, load is aerated by circulating air and hydrogen peroxide sterilant vapor through HEPA filter to remove vapor from load and chamber prior to cycle end. Vapor is converted into water and oxygen by using a built-in catalytic MnO2 converter system. The amount of residual hydrogen peroxide sterilant is measured by gas sensors . Safe opening of chamber door is ensured by both time limitation (before opening door is possible) and concentration ＜1ppm measurement.

SAFETY FEATURES

Emergency Stop Button, located on both sterile (ST) and non-sterile (NS) sides of the Unit, returns valves to safe condition and halts Cycle processing when pressed. Once pressed, operator chooses to either abort or continue Cycle operation.

User Lever Password Administration

prevents access of unauthorized users to critical operational modes. Three access levels are available:

1. Operator Level: Allows operator to select and start Cycle,

view Cycle parameters and order control to print limited

reports.

2. Service Level: Allows operator to select and start Cycle,

view Cycle parameters, print reports, calibrate instruments

and activate/deactivate inputs and outputs, edit common

settings, change date/time and view service diagnostics.

3. Administrator Level: Allows operator to select and start

Cycle, view Cycle parameters, print reports, calibrate

instruments and activate/deactivate inputs and outputs,

edit common settings, change date/time, view service

diagnostics and edit passwords.

Door Interlock allows only one door to be opened at a time,

and during processing, prevents either door from being

opened until Cycle is complete. VHP sensor interlocked with door ensures door cannot be opened before biodecontaminate concentration inside chamber is below

predetermined safety level.

CONSTRUCTION

Chamber is manufactured from AISI316L stainless steel . All chambers are designed and manufactured in accordance to application requirements

Chamber is rectangular design with applicable radius in

corners.

• Doors are sealed to chamber by active non-lubricated door

gaskets driven by air pressure.

• Electric safety key lock feature for doors provides a safety

lock system for disabling all chamber functions during

service and cleaning operations.

• As standard, inner chamber walls and doors are

mechanically polished to minimum Ra 0.6 µm or better.

• All chamber welds are ground smooth.

• All gaskets used for connections are of pharmaceutical

grade PTFE (Teflon), silicone or EPDM.

MOUNTING ARRANGEMENT

VHP PASS BOX chamber is designed for freestanding or recessed mounting through one or two walls. All unit components are integrally mounted within footprint (refer to Equipment drawing).

OPTIONS

Mirror Construction reverses standard positioning of sterilizer chamber and maintenance area. Standard configuration is chamber on left and maintenance space is on right side when looking at unit from loading/main side of

use. In Mirror construction, this arrangement is reversed and

a Chamber is on Right Side and maintenance space on left.

Trim Panel Set (Each Side) are provided for sealing gap

between Unit fascia panels and facility wall opening for recessed one or two wall installations. Panels are manufactured of AISI 304 stainless steel. Select this option

when other sealing methods such as dry wall installation or on-site sheet metal fabrication are not available. Customer’s room layout drawing is required for designing the trim panels.

Loading Cart System is custom designed and used to support and convey assorted products in loading, VHP PASS BOX and unloading process. Loading

equipment is a critical component for unit process and throughput. Product details need to be provided to optimize design of load pattern, size and weight. Some typical features include:

• Stainless-steel AISI316L frame design

六、Introduction to operation process

1、Start CONDITIONING

During the pre-conditioning phase both the chamber and the load are flushed with a strong airflow.The air is circulated through a dryer unit and HEPA filter in a closed loop configuration to enable reduction in both particulate load and chamber humidity.

2、VHP DECONTAMINATION

In the VHP Decontamination step the aqueous hydrogen peroxide solution is flash-vaporized and dispersed into the

airstream. Inside the chamber, VHP gas is circulated by the fan, ensuring even

distribution of the gas.

Principle:

1. According to the required H2O2 injection flow (e.g., 20ml/m³), the system verifies the result according to the loading capacity of each device

2. The system injects H2O2 into the heater through a flow pump, and the heater heats H2O2 into vapor at a temperature of 100-150℃.

3, with 80-100pa pressure vapor into the molecular sieve dehumidification purifier, will reduce the humidity part, the molecular sieve purifier designed a semiconductor cooler, H2O2 vapor becomes dry and low temperature effect

Generator work control:

The generator work time is controlled according to the size of VHP space and load. If: the size of work area is not the same, the parameters set need to be adopted

1, biological indicator card to verify the uniformity of sterilization,

2, biological indicators to confirm the effect of sterilization

3. On-line H2O2 sensor monitors the concentration of injection volume

Selection of H2O2 reagent:

 using analysis of pure 30%-35%

Conclusion: H2O2 sterilization injection cycle is based on flow concentration to ensure the effect of sterilization. The work is divided into concentration rise time and saturation sterilization time. Generally, the flow injection concentration reaches the required value in about 5-10 minutes, and the saturation sterilization time should not be less than 30 minutes

3、Residual exhaust stage

load is aerated by circulating VHP and air mixture through the catalyzer to remove the peroxide from the load and chamber.standard stipulates: after VHP sterilization, the concentration in the work area is not higher than 1ppm. The system adopts the principle of manganese dioxide catalysis to decompose H2O2, and the method of internal circulation and rapid effusion is used to effectively reduce the concentration in the work area.Exhaust connected with manganese dioxide catalytic converter, H14HEPA, exhaust fan, pneumatic valve, etc。

7、Configuration of the System

1. HMI standard Standard: CFR 21 Part 11, SCADA system, equipped with OPC UA communication protocol. 10 ' '

2, user management rights, operation log, alarm record, PDF production report, data backup, data recovery and other functions

VHP,VHP PASS BOX