Dynamic Pass Box Manufacturer

Dynamic Pass Box Manufacturer: An Ultimate FAQ Guide

To provide an optimal solution to the frequent opening of clean rooms, Dynamic Pass Box Manufacturer has constructed a full line of dynamic pass boxes.

Easy installation, maintenance, and lower costs are the core features of manufacturer products. Except for this, GMP compliance, ISO standard, and FDA compliance are followed in manufacturing.

Under these characteristics, Dynamic Pass Box Manufacturer is said to be the best optimal option for purchasing dynamic pass boxes.

ISO Certified Dynamic Pass Box

Who is Dynamic Pass Box Manufacturer?

Dynamic Pass Box Manufacturer is renowned for the formulation of a variety of dynamic and static pass boxes for different clean rooms.

It uses Stainless steel material, HEPA box, pressure gauges, and interlocking system for designing reliable and credible DPB.

In-house repairing and installation services are also offered by Dynamic Pass Box Manufacturer. It designs all of its pass-through cabinets according to international standards for ensuring credibility.

Sunnyda Dynamic Pass Box for Clean Room

What Principles Does a Dynamic Pass Box Manufacturer Comply for Dynamic Pass Box Manufacturing?

Dynamic Pass Box Manufacturer constructs an assorted number of pass-through just by keeping in view the contamination-free material transferring.

The basic principles which are followed for DPB formulation are:

• A dynamic airflow system is set up to prevent the entry of any airborne particulate inside a controlled environment while material transferring. Dynamically airflow pattern acts as a barrier for dirty air.

• Secondly, the dual re-circulatory airflow pattern is adjusted at both sides of DPB.

• Any particulate or contaminant that may enter while post specimen transferring is traced by a vertical purging system setup.

So, by working under these principles, Dynamic Pass Box Manufacturer helps different clean rooms in the safe manufacturing of contaminant-sensitive products.

Dynamic and Static Pass Box Manufacturing

How Does a Dynamic Pass Box Manufacturer Construct a Dynamic Pass Box?

Dynamic Pass Box Manufacturer designs a variety of dynamic pass boxes to maintain the specific containment level in material transferring.

• Submittals are prepared according to standard dimensions

• For customization services, the manufacturing company manipulates submittals and drawings according to the customer order

• Gel sealed HEPA filters or ULPA filters are prepared

• Microprocessor and visual alarms are also designed to control the air velocity

• USP class 6 compliance and FDA standards are followed while DPB designing

• Hinges are made with stainless steel material

• After completion of the framework, ISO standards PAO test, air velocity tests are performed for unit qualification
• If the results will come according to acceptance criteria, the boxes are packed for shipping.

Which Technical Specifications Does a Dynamic Pass Box Manufacturer Consider While Designing Dynamic Pass Box?

The Dynamic Pass Box Manufacturer designs a dynamic pass box with technical specifications to make it more efficient in protecting from contaminated air entrance in a cleaning zone.

These technical specifications are given below:

• An electrical interlocking system configured with doors and timers.

• LED lights for the indication of door interlocking as well as cleanliness for H14 filters.

• H14 HEPA filtration system to filter the supply air and discharge air.

• 220 to 230V power supply for unit processing and 50 to 60Hz frequency.

• Perforated grills made of stainless steel can be removed easily for cleaning.

• UV-C lamps are featured at the top section of the box to kill germs.

• The standardized dimensions of the dynamic pass box are 1000× 1500 ×h× 1270 for length, height, and width respectively but it can be customized as per customer needs.

• Pressure gauges range from 0 to 25mmwc included with motor blowers for particulate dissipation.

• Supply filter of 0.3micron and discharge filter with 10 microns for air filtration.

• Noise level ranges from 60db to 70db.

• 304 stainless steel material/316 stainless steel material/ 316L stainless steel material for cabinet construction.

DOP Testing Port and Pressure Guage of Dynamic Pass Box

With Which Basic Features Does a Dynamic Pass Box Manufacturer Construct Dynamic Pass Box?

Dynamic Pass Box is a specific unit that is used to transfer material in a clean room without contamination.

The Dynamic Pass Box Manufacturer designs it with a diverse number of features as given below:

• Designing of the whole unit under GMP compliance

• Doubled wall cabinet integrated with doors as well as glass

• 316 SS /314 SS material for cabinet construction

• Doors with an electric or magnetic interlocking system

• Megnehelic pressure gauges and centrifugal air blowers

• HEPA filters for the filtration of supply air and exhaust air

• Easy cleaning and maintenance due to GMP regulations

• Pre-installed UV lights for germicidal as well as white lights

• Re-circulatory system for airflow through filters

• Pre-filters of EU-6 and 14 grade

• Stainless steel flanges

• Touch controllers for regulating pressure display and blowers

• Air velocity measuring system

• Pressure differential measuring system

• Power supply and DOP ports

• Heavy-duty body and air tightening system

For Which Purpose Does a Dynamic Pass Box Manufacturer Construct Dynamic Pass Box?

• Dynamic Pass Box Manufacturer constructs dynamic pass boxes to reduce the need for door opening of clean rooms for the protection of contaminants from the entrance.

• For preventing any interference with the cleaning grade of any clean room, the DPB is manufactured.

• To reduce the entry of personnel with contaminant air inside a controlled environment, Dynamic Pass Box Manufacturer designs it.

• For air filtration that may come in contact while material transferring from low to high cleanliness grade, it is designed.

Prime Quality Dynamic Pass Box

What is the Functioning of Dynamic Pass Box Offered by Dynamic Pass Box Manufacturer?

Dynamic Pass Box Manufacturer is renowned for offering a wide variety of pass-through boxes.

Dynamic Pass Box works just like the laminar flow cabinet that always maintains the entry of clean air.

The main functioning for which the Dynamic Pass Box Manufacturer designs it is given below:

• The dynamic pass box is constructed with a rectangular shape. The cabinet is configured with two doors.

• One door opens at the clean room side for specimen transferring. While the other door is on the outside or a room depending on your site of installation.

• Both doors are assimilated with glass windows for observing the specimen that is placed in the cabinet for transferring.

• The doors opening and closing system is equipped with an electrical interlocking system that controls the opening of one door at one time.

• In this way, the direct entry of outside air inside the clean room is restricted.

• The dynamic pass box also minimizes the direct clean room opening for specimen transferring.

• DPB is designed in such a way that the cleanliness grade of any clean room may not get disturbed while material transferring from low to high cleaning zone

The supply air, as well as discharged air, is filtered by HEPA filters integrated inside the dynamic pass box. The re-circulatory airflow system is set inside the box.

• This box is featured with a pressure controlling system that ensures the protection of clean rooms from contamination by allowing only clean air to pass from the box that will be according to cleanliness grade.

Dynamic Pass Box With Interlocking System

How is a Static Pass Box Different from Dynamic Pass Box Designed by a Dynamic Pass Box Manufacturer?

Dynamic pass boxes and static pass boxes are designed differently from each other to meet the needs of different applications and ISO cleanrooms as given below:

Static Pass Box

• Static pass boxes are used for those applications that are having both clean rooms with equal cleanliness grades. So static pass boxes transfer material from one cleaning zone to other cleaning zones without the entrance of air.

• The static pass box is featured with an electromagnetic interlocking system fitted at the center of the door. A LED light is also integrated with interlocks as an indicator if the door is open.

• There is no filter present inside the clean rooms for the air filtration as in the dynamic pass box.

• The static pass box does not have any pressure gauges for the discharge of dusty particulates but instead, it is designed with an air-lock system that doesn’t allow the entrance of air.

• Static pass does not have interlocking guards system to allow the opening of one door or outlet and closing of the inlet door at one time.

It doesn’t require this because only material is transferred between equally cleaned environments.

Dynamic Pass Box

• It is always preferred to use for material transferring between a controlled environment and a contaminated outside environment.

So one application is always equipped with a cleanliness grade while the other is with an open environment between which the DPB is fitted.

• The dynamic pass box is featured with an electrical interlocking system that mediates the opening of one door while the material is placed inside the box.

At the side of the clean room, the second door does not open till the outside door is not closed. No LED indicators are used.

• Dynamic pass box contains filter system. 0.3micron suction filter is fitted at air supply for removal of airborne particulates. While a 0.9 micron supply filter is integrated for discharge air filtration.

• It also has a pressure gauge system integrated with blowers to dissipate the contaminants and airborne particulates.

• Dynamic Pass Box Manufacturer configures its dynamic pass boxes with an interlocking guard that triggers the opening of the outlet when the inlet is closed and prevents the entry of contaminated air inside the cleanroom from the outside environment.

Which Accessories Does a Dynamic Pass Box Manufacturer Integrate With a Dynamic Pass Box?

Dynamic Pass Box Manufacturer provides dynamic pass boxes for aseptic transferring of specimens to a controlled environment.

Some of the accessories options are also integrated for efficient working as given below:

• Auto sliding doors made of PVC

• UV lights or LED lights

• Rocker switches for the release of interlocking system

• Shelves for internal box

• Special buttons connected to the door for its release

• Customizing blowers configured with alarms for fan fault detection

• Fire-rated, intercom system, and ATEX rated

• Buzzer system to alert the worker on the other side for material receiving

• Roller conveyors, supporting stand for DPB, and rails

For Which Applications Does a Dynamic Pass Box Manufacturer Design Dynamic Pass Box?

Dynamic Pass Box Manufacturer constructs a wide variety of dynamic pass boxes for a wide variety of applications as given below:

• Pharmaceutical Industries

• Clean Rooms

• Research Laboratories

• Semiconductors Manufacturing

• Vaccines Developing Companies

• Electronic Industries

• Food Processing Companies

• Educational Institutes

• Medical Departments

• Chemical Laboratories

Dynamic Pass Box Applications

Which Models of DPB Does a Dynamic Pass Box Manufacturer Offer you?

Dynamic Pass Box Manufacturer offers different models of dynamic pass boxes for different applications as:

• DPB with 304 stainless steel base and outside surfacing made of A-EG steel

• S1-The full unit made of 304 stainless steel material with rounded corners at the inside box

• S2- The whole unit is made of 316L stainless steel material and rounded corners inside the box

• CMB- It designs with different combinations

For Which ISO Clean Room Classes Does a Dynamic Pass Box Manufacturer Provide DPB?

Dynamic Pass Box Manufacturer designs DPB for a wide variety of applications and different clean rooms.

The clean rooms that are sensitive to airborne particulates and contaminants are featured with pass-through cabinets to mitigate the need for clean room door opening.

The customers mostly prefer to use dynamic pass boxes for class 1 clean room and class 100 clean room.

Except for this ISO 5 clean room, ISO 6 clean room and the ISO 7 clean room cleaning grade are kept in consideration, and dynamic pass boxes are designed to maintain the required number of particulate count.

ISO 5 Cleanroom Dynamic Pass Box

Which Airflow Pattern Does a Dynamic Pass Box Manufacturer Configured With a Dynamic Pass Box?

The Dynamic Pass Box Manufacturer constructs the dynamic pass boxes with a re-circulatory airflow pattern to dissipate the contaminants and airborne particulates from entering into a sterile room.

During operation, the air enters inside the dynamic pass box. After that, it is drawn through G4 pre-filters integrated inside the box.

A large number of particulates are removed by the G4 filter to lessen the burden on the main filter.

After filtration, the downflow air is forced by H14 knife gel sealed filters resulting in streamlined vertical laminar airflow.

The air is recirculated inside the chamber by a G4 filter before passing through the H14 filter for downflow.

A single-pass air circulatory system can also be configured with the box but mostly it is prepared on customer demands.

Which Filters Does a Dynamic Pass Box Manufacturer Use in a Dynamic Pass Box for Maintaining EU 14 Cleaning Grade?

Dynamic Pass Box Manufacturer configured the DPB with high-efficiency filters to discharge the contaminants and airborne particulates from the air while material transferred between two different cleaning zones.

• G4 pre-filters discharge a large number of particulates from the air.

• HEPA H 14 filters for the filtration of recirculating downflow air ensuing 995 percent filtration activity for particulates of 0.3 microns.

These filters work under EU 14 and EU 6 cleaning grades depending on the application requirements.

Dynamic Pass Box Primary Filter

How to Monitor your Dynamic Pass Box Under Directions Provided by Dynamic Pass Box Manufacturer?

Dynamic Pass Box Manufacturer avails you with stand-alone dynamic pass boxes. Except for installation and repair services, the manufacturer also provides directions to monitor the accurate working of DPB as given below:

Step 1

First, prepare the agar plates containing soybean casein with glycerol according to the provided SOPs.

Step 2

Then place the agar plates for incubation at temperature ranges from 30⁰C to 35⁰C for one day. Complete this process before exposure.

Step 3

Turn on the dynamic pass box for almost thirty minutes before placing an agar plate inside it for exposure.

Step 4

After that, place the plate inside DPB for exposure for almost four hours. Set up plates on two locations in the cabinet for making passive air sampling and place at one location for active air sampling process by using 1000L air.

Step 5

For getting bacterial colonies on prepared agar plates, again set the incubating conditions as 30⁰C – 35⁰C, and the time should be between 48hours- 72hours.

While 20⁰C -25⁰C temperature is setup for incubation to attain fungal colonies on agar plates with time ranges from 48hours to 72hours.

Step 6

Add results in annexure 3 about total viable counts on agar plates to monitor the working efficiency of the dynamic pass box.

While the negative plate is not undertaken for exposure, take it without exposure for final results updating.

Step 7

Maintain the box if there would be an error. This monitoring process can repeat in a week.

Except for this monitoring procedure also inspect the UV light. These lights should remain turned off when the door is opened.

Which Quality Tests are Performed by Dynamic Pass Box Manufacturer to Hit the Acceptance Criteria?

Different category quality tests are performed to check the validity of DPB according to different standards as given below:

DOP or PAO Testing

• DOP test is performed to measure the integrity of the HEPA filter box that is configured with dynamic pass boxes. Any leakage in the HEPA filter is also monitored under this test.

• To perform this test, an aerosol oil is used for up-streaming on the filter with 100% challenge. While downstream, the HEPA filter integrity and any leakage are scanned.

• The aerosol is getting mixed with the incoming air so that it may come in contact with all filters for exposure.

• After exposure with aerosol, the filter perimeter is scanned by using probes and these are held on the filter at about 25mm distance.

• The acceptance criteria are that no aerosol leakage on the photometer should have penetration above 0.01%.

Particulates Count Test

• To measure the number of particles in the cabinet, a specific particle counter is used.

• A particle counter is placed in the center of the workplace.

• Before starting the process, make sure to clean a particle counter.

• Turn on the blower of the dynamic pass box for about 1 hour before processing.

• Get the readings of particle count by taking a sample from 5 locations.

• The DPB is considered to be standardized and reliable if the size of particles would be 0.5 micron and total particles should not be above 100 in one cubic foot of air.

Air Velocity Test

• The pass box is turned on and airflow velocity is measured by using the anemometer.

• According to acceptance criteria, the airflow velocity should be 90 ± 20 feet per minute.

Dynamic Pass Box PAO_DOP Testing Ports

Under Which Standardized Certifications Do a Dynamic Pass Box Manufacturer Design its Products?

Dynamic Pass Box Manufacturer performs different qualification protocols to accredit its products with standardized certifications as given below:

ISO Certification

Although there are no specific standards are set for dynamic pass box manufacturing.

The Dynamic Pass Box Manufacturer follows ISO 14644 compliance for designing DPB for different clean room classes. ISO certifications make the pass-through credible for customers.

CE Certification

CE certifications enable the DPB to introduce among European applications by keeping into consideration the personnel safety, health, and environmental concerns.

FDA Certifications

The pass-through boxes are FDA approved. Food grade approval ensures that the box is suitable and protected for foodstuff when comes in contact with the box.

The FDA approvals make the DBP more reliable to use for clean rooms involves in food processing.

USP Compliant Certification

USP compliant of class 6 is also followed for standardized qualification of dynamic pass box. Under this compliant, the designed product is considered to be biocompatible for medical clean rooms.

What is USP Class 6 Compliance Undertaken by Dynamic Pass Box Manufacturer for the Formulation of Dynamic Pass Box?

USP Class 6 compliance is the standardized guidelines designed by the Pharmacopeia Convention of the U.S for different health care technologies and medical applications.

This standard infers the testing protocols to check the biocompatibility and safety of material used for medical appliances.

The Dynamic Pass Box Manufacturer follows USP compliance to ensure that the dynamic pass boxes are safe and sterile for medical applications.

The cabinets and materials that are approved by USP compliance are considered to qualify for FDA standards.

How Does FDA Approvals Help Dynamic Pass Box Manufacturer Ensuring its Products Credibility?

FDA compliant dictates about the food and drugs administration. Dynamic Pass Box Manufacturer designs its dynamic pass boxes for food processing clean rooms and pharmaceutical clean rooms that deal with drugs designing.

The manufacturer works under food grade approvals from FDA that ensure that the pass-through cabinets are safe and protective for food and drugs material.

It also ensures that the DPB when comes in contact with food processing material, does not react with it to damage it or make it harmful.

FDA Approved Dynamic Pass Box for ISO 1 Clean Room

What is Recovery Test Performed by a Dynamic Pass Box Manufacturer?

The Dynamic Pass Box Manufacturer performs a recovery test to evaluate the ability of the dynamic pass box to come into its original cleanliness grade after exposure to contaminated air.

Two ways are used to perform this test as given below:

First Method

According to ISO 14644-3 sampling process is performed near the workplace or in the center of the workplace.

The existing level of particulate concentration is measured. But to find out this, the total required particulate count is measured first.

After that, an aerosol is particularly used for particles challenge with 100 times more cleanliness level as compared to the desired one.

At the start of the challenge, note the starting time and then measure concentrations. The challenge concentration is taken in 1-6 seconds per minute until the unit comes back to its original cleaning grade.

Second Method

In the second method, it is assumed that the air supply will be with zero particulate concentration. The initial room concentrations are calculated. For final air concentration on DPB recovery, the following equation is used.

Cr_rest = (Cr_op- Cs) ×e^-NT+ Cs

Where Cr_rest represents the final room concentration, Cr_op is about initial concentration, and Cs is the particulate-free air supply concentration. ‘T’ is for the time taken and ‘N’ is the number of particulates.

According to EU GMP compliance, 15 to 20 minutes are standard for the recovery of the pass box from operational state to its final cleanliness state.

The results of the recovery test that will come according to EU GMP indicate the validity of the DPB.

What are Installation Services Offered by Dynamic Pass Box Manufacturer for DPB?

Dynamic Pass Box Manufacturer not only facilitates you with a variety of dynamic pass boxes but also offers installation, unit repairing, monitoring, and qualification services.

Wall-mounted installation and floor mounting installation services are offered depending upon the material you have to transfer between clean rooms.

Location is selected according to the layout of the box and SOPs are followed.

According to installation drawings, our service team installs the dynamic pass box. The clean room panels are cut down according to the dimensions of the box.

Shifting of already installed pass boxes from one position to the other is also offered with qualification testing.

What are the Customization Services that a Dynamic Pass Box Manufacturer Offered you?

Dynamic Pass Box Manufacturer offers you the customization services as:

• Release buttons for door opening are added instead of an automatic electrical interlocking system to customize DPB for your application.

• Dynamic Pass Box Manufacturer also offers a single pass air flow pattern instead of a recirculation airflow pattern of standardized clean rooms.

• The standardized dimensions for the dynamic pass-through can be changed as per your application requirements.
• HEPA filters can be replaced with ULPA filters inside the pass-through box if your application requires more efficient cleaning grades.

Customized Dynamic Pass Box

Conclusion.

The Dynamic Pass Box Manufacturer is the most reputed and renowned among the users of clean rooms that are looking for sterile and aseptic ways for specimen transfer from outside to inside clean area.

The DPB that is designed acts as a bridge between two clean rooms for safe contaminated-free material shifting.

Dynamic Pass Box Manufacturer also offers standardized and customized pass boxes with easy installation and maintenance.

USP, FDA approval, and ISO certified dynamic pass box have now become the more desirable unit among clients.

CE Certified 100% Quality Tested Pass Box