What is Pass Box

Spot Extractor

A clean room is a room where the concentration of particles is minimized. Temperature, humidity and pressure parameters are also controlled.

Operators use particular clothes (foot booties, coat, hairnet and gloves) to avoid dirtying the room.

Clean rooms are used for the industry or research fields, which are sensible domains to environmental contamination (biology, construction of spacecraft, optical manufacturing or semiconductors…).

To cope with rising demands of optics and space applications, an ISO 7 (class 10 000) clean room has been installed to minimize the presence of particles such as dust to enable the integration of “clean” and vacuum compatible hexapods.

In the space sector, we regularly deliver ISO 5 compatible systems, for which we follow the design and assembly rules related to the cleanliness of the ISO 5 environment.

A cleanroom or clean room is an engineered space, which maintains a very low concentration of airborne particulates. It is well isolated, well-controlled from contamination, and actively cleansed. Such rooms are commonly needed for scientific research, and in industrial production for all nanoscale processes, such as semiconductors & medicine manufacturing. A cleanroom is designed to keep everything from dust to airborne or vaporized particles, away from it, and so from whatever material is being handled inside it.

Cleanrooms typically come with a cleanliness level quantified by the number of particles per cubic meter at a predetermined molecule measure. The ambient outdoor air in a typical urban area contains 35,000,000 particles for each cubic meter in the size range 0.5 μm and bigger, equivalent to an ISO 9 certified cleanroom. By comparison an ISO 14644-1 level 1 certified cleanroom permits no particles in that size range, and just 12 particles for each cubic meter of 0.3 μm and smaller. Semiconductor facilities often get by with level 7, while level 1 facilities are exceedingly rare.

Some cleanrooms are kept at a positive pressure so if any leaks occur, air leaks out of the chamber instead of unfiltered air coming in. This is most typically the case in semiconductor manufacturing, where even minute amounts of particulates leaking in could contaminate the whole process, while anything leaking out would not be harmful to the surrounding community. The opposite is done e.g. in the case of high level bio-laboratories, handling contaminous viruses; those are always held at negative pressure, with the exhaust being passed through high efficiency filters, and further sterilizing procedures. Both are still cleanrooms, because the particulate level inside is maintained within very low limits.

Some cleanroom HVAC systems control the humidity to such low levels that extra equipment like air ionizers are required to prevent electrostatic discharge problems. This is a particular concern within the semiconductor business, because static discharge can easily damage modern circuit designs. On the other hand, active ions in the air can harm exposed components as well. Because of this most workers in high electronics and semiconductor facilities have to wear conductive boots while working. Low-level cleanrooms may only require special shoes, with completely smooth soles that do not track in dust or dirt. However, for safety reasons, shoe soles must not create slipping hazards. Access to a cleanroom is usually restricted to those wearing a cleanroom suit, including the necessary machinery.

In cleanrooms in which the standards of air contamination are less rigorous, the entrance to the cleanroom may not have an air shower. An anteroom (known as a “gray room”) is used to put on clean-room clothing. This practice is common e.g. in many nuclear power plants, which operate as low-grade inverse pressure cleanrooms, as a whole.

Recirculating vs. One pass cleanrooms

Recirculating cleanrooms return air to the negative pressure plenum via low wall air returns. The air then is pulled by HEPA fan filter units back into the cleanroom. The air is constantly recirculating and byu continuously passing thru HEPA filtration removing particles from the air each time. Another advantage of this design is air conditioning can be incorporated.

One pass cleanrooms draw air from outside the cleanroom, pass it thru HEPA fan filter units into the cleanroom. The air then leaves thru exhaust grills to outside the cleanroom. The advantage of this approach is the lower cost. The disadvantages are short HEPA fan filter live, worse particle counts than similar recirculating cleanroom, and cannot accommodate air conditioning.

Clean room Classification

ClassMaximum particles/m3FED STD 209E equivalent
≥0.1 µm≥0.2 µm≥0.3 µm≥0.5 µm≥1 µm≥5 µmCleanroom
Grade
ISO 110
ISO 21002410
ISO 31 00024710235Class 1
ISO 410 0002 470102035283Class 10
ISO 5100 00024 70010 2003 520832Class 100A
ISO 61 000 000247 000102 00035 2008 320293Class 1 000B
ISO 7352 00083 2002 930Class 10 000C
ISO 83 520 000832 00029 300Class 100 000D
ISO 935 200 0008 320 000293 000Room air
GradeMaximum limits for total particle ≥0.5µm/m³Maximum limits for total particle ≥0.5µm/m³Maximum limits for total particle ≥5.0µm/m³

Maximum limits for total particle ≥5.0µm/m³

At restIn operationAt restIn operation
A3,5203,520Not specifiedaNot specifieda
B3,520352,000Not specifieda2,930
C352,0003,520,0002,93029,300
D3,520,000Not predeterminedb29,300Not predeterminedb

Classification including 5µm particles may be considered where indicated by the CCS or historical trends.

b For grade D, in operation limits are not predetermined. The manufacturer should establish in operation limits based on a risk assessment and routine data where applicable.

What is Pass Box?

Complete Guide to Static and Dynamic Pass Boxes for Pharmaceutical Cleanrooms

A Pass Box is a specialized cleanroom equipment used in pharmaceutical facilities to transfer materials between two controlled areas without allowing direct human movement between those areas. It helps maintain the cleanliness, sterility, and contamination control required in pharmaceutical manufacturing environments.

In pharmaceutical cleanrooms, maintaining strict hygiene and preventing contamination are critical for ensuring the quality and safety of medicines and sterile products. A pass box acts as a secure transfer chamber that allows items such as raw materials, tools, documents, or equipment to be passed from one room to another while minimizing the risk of contamination.

Brinda Pharma Technologies Private Limited designs and manufactures high-quality pass boxes that support contamination control and efficient material transfer in pharmaceutical cleanrooms and controlled environments.

What is a Static Pass Box?

A Static Pass Box is a cleanroom equipment used in pharmaceutical and biotechnology facilities to transfer materials between two areas with the same cleanroom classification while minimizing contamination risks. It acts as a sealed chamber installed in the wall between two controlled environments, allowing safe and efficient material transfer without direct personnel movement.

Static pass boxes are widely used in pharmaceutical manufacturing areas where airflow control is not required, but contamination prevention and cleanroom discipline are still important.

How a Static Pass Box Works

A Static Pass Box is a cleanroom equipment used in pharmaceutical and biotechnology facilities to transfer materials between two areas with the same cleanroom classification while minimizing contamination risks. It acts as a sealed chamber installed in the wall between two controlled environments, allowing safe and efficient material transfer without direct personnel movement.

Static pass boxes are widely used in pharmaceutical manufacturing areas where airflow control is not required, but contamination prevention and cleanroom discipline are still important.

Key Features of a Static Pass Box

  • Door interlocking system to prevent simultaneous opening.
  • Stainless steel construction (SS 304 or SS 316) for durability and easy cleaning.
  • Smooth internal surfaces to reduce particle accumulation.
  • Optional UV light for sterilization.
  • GMP-compliant design for pharmaceutical cleanrooms.

Applications in Pharmaceutical Facilities

Static pass boxes are commonly used in:

  • Pharmaceutical manufacturing areas.
  • Cleanroom packaging zones.
  • Quality control laboratories.
  • Research and development laboratories.
  • Material transfer between similar cleanroom grades.

Advantages of Static Pass Boxes:

  • Reduces human traffic in cleanrooms.
  • Prevents cross-contamination during material transfer.
  • Maintains cleanroom discipline and operational efficiency.
  • Supports Good Manufacturing Practices (GMP) requirements.

Brinda Pharma Technologies Private Limited manufactures high-quality static pass boxes designed to meet pharmaceutical cleanroom standards and ensure safe, contamination-controlled material transfer.

In summary, a static pass box is an essential cleanroom device that provides simple, reliable, and contamination-controlled transfer of materials between similar cleanroom environments in pharmaceutical facilities.

What is a Dynamic Pass Box?

A Dynamic Pass Box is a cleanroom equipment used in pharmaceutical and biotechnology facilities to transfer materials between areas with different cleanroom classifications while maintaining strict contamination control. Unlike a static pass box, a dynamic pass box is equipped with an air filtration system, typically using HEPA filters, to ensure that the air inside the chamber remains clean during the material transfer process.

Dynamic pass boxes are commonly installed in critical pharmaceutical environments where maintaining high levels of cleanliness and sterility is essential.

How a Dynamic Pass Box Works

A dynamic pass box operates with a built-in blower and HEPA filtration system that continuously circulates and filters air inside the chamber. The filtered air removes dust particles, microorganisms, and other contaminants, ensuring that materials remain clean during transfer.

The unit also includes an electromagnetic interlocking door system, which ensures that only one door can be opened at a time. This prevents air mixing between two areas with different cleanliness levels.

Key Features of a Dynamic Pass Box:

  • HEPA filtration system with 99.97% efficiency at 0.3 microns.
  • Blower motor for continuous airflow.
  • Electromagnetic door interlocking system.
  • Stainless steel construction (SS 304 or SS 316).
  • Optional UV light for additional sterilization.
  • GMP-compliant design for pharmaceutical cleanrooms.

Applications in Pharmaceutical Facilities:

  • Sterile drug manufacturing areas.
  • Aseptic processing zones.
  • Microbiology laboratories.
  • Biotechnology research facilities.
  • Critical cleanroom environments.

Advantages of Dynamic Pass Boxes:

  • Provides higher contamination control compared to static pass boxes.
  • Maintains cleanroom air quality during material transfer.
  • Prevents cross-contamination between different cleanroom grades.
  • Supports GMP and regulatory compliance.
  • Improves safe and efficient material handling.

Brinda Pharma Technologies Private Limited manufactures high-quality dynamic pass boxes designed to meet the strict contamination control requirements of pharmaceutical and biotechnology industries.

In summary, a dynamic pass box is an advanced cleanroom solution that ensures safe material transfer, air filtration, and contamination control between different cleanroom environments in pharmaceutical facilities.

What is the Difference Between Static and Dynamic Pass Boxes?

Static Pass Boxes and Dynamic Pass Boxes are both used in pharmaceutical cleanrooms to enable safe transfer of materials between controlled environments while preventing contamination. However, they differ significantly in design, airflow mechanism, filtration system, contamination control level, and cleanroom application.

Below is a more technical comparison used in pharmaceutical and GMP-compliant facilities:

Technical ParameterStatic Pass BoxDynamic Pass Box
Primary FunctionMaterial transfer between same grade cleanrooms without airflow controlMaterial transfer between different cleanroom grades with active airflow control
Airflow SystemNo airflow system presentIntegrated forced airflow system with blower motor
Filtration SystemNot applicableHEPA Filter (99.97% efficiency at 0.3 micron particles)
Air Velocity Inside ChamberNot applicableTypically 0.45 m/s ± 20% laminar airflow
Pressure DifferentialNo pressure controlMaintains positive pressure within chamber to prevent contamination ingress
Cleanroom CompatibilityISO 7 to ISO 7 or similar classificationISO 8 to ISO 7 / ISO 7 to ISO 5 transfer environments
Door Interlocking MechanismMechanical or electromagnetic interlockElectromagnetic interlocking with control system
Construction MaterialSS 304 / SS 316 stainless steelSS 304 / SS 316 stainless steel
Internal Surface FinishSmooth matte or mirror finish for easy cleaningGMP-compliant smooth finish with rounded corners
UV SterilizationOptional UV lampOptional UV lamp with safety timer
Electrical ComponentsMinimal electrical system (interlocking control)Blower motor, control panel, pressure gauges, filter housing
Contamination Control LevelBasic contamination preventionHigh contamination control with filtered airflow
Energy ConsumptionLow (no motor or filtration)Moderate due to blower and filtration system
Maintenance RequirementLow maintenanceRequires periodic HEPA filter replacement and airflow validation
Typical ApplicationsPackaging areas, secondary production zonesSterile manufacturing, aseptic processing areas
ComplianceGMP compatible for non-critical zonesGMP compliant for critical cleanroom operations

Notes:

  • Static Pass Boxes are simple, cost-effective solutions for transferring materials between areas with similar cleanliness levels.
  • Dynamic Pass Boxes are more advanced systems that use HEPA filtration and controlled airflow to maintain high levels of cleanliness when transferring materials between different cleanroom classifications.

Brinda Pharma Technologies Private Limited manufactures both Static Pass Boxes and Dynamic Pass Boxes engineered to meet pharmaceutical GMP standards, contamination control requirements, and cleanroom operational efficiency.

Which Type of Pass Box is Suitable for Pharmaceutical Cleanrooms?

The type of pass box suitable for pharmaceutical cleanrooms depends on the cleanroom classification, contamination control requirements, and the areas between which materials are being transferred. In pharmaceutical facilities, both Static Pass Boxes and Dynamic Pass Boxes are commonly used, but each serves a different purpose based on the cleanliness level and application.

Static Pass Box

A Static Pass Box is suitable for transferring materials between cleanroom areas that have the same cleanliness classification. Since both areas maintain similar environmental conditions, an airflow or filtration system is not required.

Suitable for:
  • Transfer between similar cleanroom grades (e.g., ISO 7 to ISO 7)
  • Packaging areas
  • Secondary production zones
  • Quality control laboratories
Advantages:
  • Simple design and operation
  • Lower installation and maintenance cost
  • Effective for basic contamination control

Dynamic Pass Box

A Dynamic Pass Box is suitable for pharmaceutical cleanrooms where materials are transferred between areas with different cleanliness levels. It includes a HEPA filtration system and controlled airflow, which helps remove airborne particles and maintain cleanroom integrity.

Suitable for:
  • Transfer between different cleanroom grades (e.g., ISO 8 to ISO 7 or ISO 7 to ISO 5)
  • Sterile drug manufacturing areas
  • Aseptic processing zones
  • Microbiology laboratories
  • Biotechnology research facilities
Advantages:
  • Higher level of contamination control
  • Maintains filtered airflow inside the chamber
  • Prevents cross-contamination between critical cleanroom areas
  • Static Pass Boxes are ideal for non-critical transfers between similar cleanroom environments.
  • Dynamic Pass Boxes are recommended for critical pharmaceutical operations where strict contamination control and filtration are required.

Brinda Pharma Technologies Private Limited manufactures high-quality static and dynamic pass boxes designed to meet pharmaceutical GMP standards and cleanroom contamination control requirements. These pass boxes ensure safe and efficient material transfer in pharmaceutical manufacturing and laboratory environments.

FAQ's

What are the Main Components of a Pass Box?

The main components of a pass box include the stainless steel chamber, interlocking doors, viewing glass, door handles, and control panel. Dynamic pass boxes also include HEPA filters, blower motor, and airflow system. These components ensure safe material transfer while maintaining cleanroom conditions.

Why are Interlocking Doors Important in Pass Boxes?

Interlocking doors prevent both doors from opening at the same time, which helps avoid air mixing between two controlled environments. This feature maintains cleanroom pressure balance and contamination control. It is essential for maintaining GMP-compliant cleanroom operations.

What Materials are Used in Pharmaceutical Pass Boxes?

Pharmaceutical pass boxes are typically made from SS 304 or SS 316 stainless steel due to their durability, corrosion resistance, and ease of cleaning. The internal surfaces are smooth to prevent particle accumulation. Toughened glass is often used for the viewing window.

What is the Role of UV Light in Pass Boxes?

UV light in a pass box helps reduce microbial contamination inside the chamber. It is used to disinfect the internal area before or after material transfer. This feature supports additional hygiene control in pharmaceutical cleanroom environments.

What Safety Features Should a Pass Box Include?

A pass box should include door interlocking systems, emergency door release, UV safety switch, and indicator lights. Dynamic pass boxes may also include HEPA filter monitoring and pressure gauges. These safety features help ensure safe operation and contamination control.

Brinda Pharma Technologies Private Limited designs pass boxes with advanced safety and GMP-compliant features for pharmaceutical cleanrooms.

How to Clean a Pass Box in a Pharmaceutical Cleanroom?

Cleaning a pass box in a pharmaceutical cleanroom is essential to maintain sterility, contamination control, and GMP compliance. The cleaning process should follow standard cleanroom procedures using approved disinfectants and proper handling methods.

  1. Prepare the Cleaning Materials
    Use approved cleanroom disinfectants such as 70% Isopropyl Alcohol (IPA), sterile wipes, and lint-free cloths. Ensure that operators wear proper cleanroom garments, gloves, and masks before starting the cleaning process.
  2. Clean the Internal Chamber
    Open one door of the pass box and clean the internal surfaces using lint-free wipes soaked in disinfectant. Wipe from top to bottom and from clean areas to less clean areas to avoid spreading contamination.
  3. Clean Doors and Handles
    Carefully clean the doors, handles, and viewing glass using disinfectant wipes. These areas are frequently touched and may carry contamination.
  4. Disinfect with UV Light (if available)
    If the pass box has a UV sterilization system, activate it for the recommended time to help reduce microbial contamination inside the chamber.
  5. Clean the External Surfaces
    Wipe the outer surfaces of the pass box, including the door frame and surrounding area, to maintain overall cleanroom hygiene.
  6. Follow Regular Cleaning Schedule
    Pass boxes should be cleaned daily or as per the cleanroom standard operating procedures (SOPs) to ensure continuous contamination control.

Brinda Pharma Technologies Private Limited designs pharmaceutical pass boxes with smooth stainless steel surfaces and GMP-compliant construction, making them easy to clean and maintain in cleanroom environments.

Pass Box, Cleanroom Pass Box, Static Pass Box, Dynamic Pass Box, Pharmaceutical Pass Box, Cleanroom Material Transfer Box, Pass Box for Cleanroom, Cleanroom Transfer Hatch, Stainless Steel Pass Box, Pass Box for Pharmaceutical Industry, Pass Box Manufacturer, Cleanroom Pass Box Manufacturer, Static Pass Box Manufacturer, Dynamic Pass Box Manufacturer, Pharmaceutical Pass Box Manufacturer, Cleanroom Equipment Manufacturer, Pass Box Supplier, Pass Box Manufacturer India, Cleanroom Pass Box Supplier, Pass Box for Pharmaceutical Manufacturing, Pass Box Manufacturer India, Pass Box Manufacturer USA, Cleanroom Pass Box Supplier Europe, Pass Box Manufacturer UAE, Pass Box Supplier Saudi Arabia, Cleanroom Equipment Manufacturer India, Pass Box Manufacturer Hyderabad

    Contact Us Today, For a Free Quote

    * For information about how we handle personal data, see our privacy statement.