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Fri May 13, 2022

GMP Pass Box

GMP Pass Box

A GMP (Good Manufacturing Practice) Pass Box is a specialized piece of equipment used in controlled environments, such as cleanrooms, to transfer materials between different areas without compromising the cleanliness and integrity of those areas. Here are the key features and functions of a GMP Pass Box:

  1. Material Transfer: Allows for the transfer of materials and products between different classified areas of a cleanroom without direct human intervention, minimizing the risk of contamination.

 

  1. Airflow Control: Equipped with HEPA filters and often has a laminar airflow system to ensure that any particulate matter is filtered out, maintaining a clean environment inside the pass box.

 

  1. Interlocking Doors: Features interlocking doors that prevent both doors from being opened simultaneously, ensuring that the cleanroom remains sealed off from potential contaminants during the transfer process.

 

  1. Construction Materials: Made from materials that are easy to clean and disinfect, such as stainless steel, to meet the stringent cleanliness requirements of GMP standards.

 

  1. Control Systems: May include UV lights, automatic door operation, and alarm systems to enhance the safety and efficiency of the transfer process.

 

  1. Compliance: Designed to meet GMP regulations, which are essential for industries such as pharmaceuticals, biotechnology, and food manufacturing where maintaining product quality and safety is critical.

 

The term "GMP pass box" typically refers to a pass-through box used in facilities adhering to Good Manufacturing Practices (GMP). These are used to transfer materials between rooms of different cleanliness levels without compromising the controlled environment of the cleanroom. Here are some key points about GMP pass boxes:


Purpose

  • Contamination Control: Prevents contamination by ensuring materials can be transferred without personnel moving between rooms.
  • Efficiency: Facilitates smooth and quick transfer of materials, maintaining the integrity of both the cleanroom and the items being transferred.

Types:

 

1. Static Pass Box

  • No air circulation.
  • Used for simple transfers without the need for decontamination.

 

2. Dynamic Pass box

  • Equipped with HEPA filters.
  • Airflow mechanism to maintain pressure and cleanliness.
  • Used for transferring materials that need to remain sterile or free from contamination.

Features

  • Interlocking Doors: Ensures one door cannot be opened until the other is closed to maintain environmental control.
  • Material: Typically made from stainless steel to ensure easy cleaning and durability.
  • UV Lamps: Some models include UV lamps for additional sterilization.

Applications

  • Pharmaceutical Manufacturing: For transferring raw materials, components, and finished products.
  • Biotechnology: In laboratories and production areas to maintain a sterile environment.
  • Microelectronics: Used in semiconductor fabrication plants to prevent contamination of sensitive materials.

 

Standards

  • Must comply with GMP guidelines, which include specifications for construction, operation, and maintenance.
  • Should be validated regularly to ensure they meet the necessary cleanliness and operational standards.

Benefits

  • Maintains Cleanroom Integrity: By controlling the transfer process, the cleanroom environment is protected from contamination.
  • Reduces Cross-Contamination: The controlled environment minimizes the risk of contaminants being transferred between rooms.
  • Enhances Safety: Protects both products and personnel by ensuring a sterile transfer process.

Static Pass Box Specifications

Construction

Stainless Steel 304 Grade

Dimensions

300x300x300mm/450x450x450mm/600x600x600mm Or Customized

Door

With Electromagnetic Lock

Window

Fitted With Tempered Glass

Electricals

LED Light, UV Light, Electromagnet For Door Interlocking, Buzzer And Indicating Lamps

UV Lamp

Germicidal Activity

Power Supply

Work On 220 / 230 Volts AC


 

Dynamic Pass Box Specifications

Construction

Stainless Steel 304 Grade

Dimensions

300x300x300mm,450x450x450mm,600x600x600mm Or Customized

Door

With Electromagnetic Lock

Window

Fitted With Tempered Glass

Electricals

LED Light, UV Light, Electromagnet For Door Interlocking, Buzzer And Indicating Lamps

UV Lamp

Germicidal Activity

Hepa Filters

Having Efficiency Rating As High As 99.99% Thus Retaining All Air-Home Borne Particles Of Size 0.3 µ And Larger.

Accessory

Manometer / Magnahelic Gauge

Blower Motor

Standard

Power Supply

Work On 220 / 230 Volts AC

 


Conclusion

Implementing GMP pass boxes is crucial for maintaining the quality and safety standards in environments where contamination control is paramount.Maximize your production efficiency with clean room equipment! We are a leading Pass Box manufacturers based in India and have a long successful experience in designing, manufacturing and installing such equipment all over India. Here at Accumax India, we are presenting Dynamic pass box equipment. These pass boxes are custom designed, rugged, made of high grade stainless steel and can be installed in a number of ways, depending on the wall or door that will support them. These pass boxes are supplied in pharmaceutical, semiconductor and food industries to meet the most demanding controlled environment conditions.Get Clean room Dynamic and Static pass box price and specifications from Accumax India.