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4 x 5M ISO 5 Modular Cleanroom

Reference Price:US$11300-13000

Short Description:

The 4 x 5 meter ISO 5 modular cleanroom is a customizable controlled environment that ensures a high level of cleanliness by filtering out 99.97% of airborne particles 0.3 micrometers and larger, making it suitable for critical applications in industries such as pharmaceuticals, biotechnology, and electronics manufacturing.

  • Anti-Static:
  • frames: Iron Cube
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  • size:
  • FFU: AC Fans
  • noise:
  • mobile pulley: Yes
  • Product Certification: ASHRAE 110 ASTM E84 CAN/CSA C22.2 CE NFPA 45
  • customs code:
  • production state: Production

Cleanroom

4 x 5M ISO 5 Modular Cleanroom

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Summary

Cleanroom

4 x 5M ISO 5 Modular Cleanroom

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Validation

Installation & Validation

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Cleanrooms Detail

An ISO 5 modular cleanroom is a controlled environment that meets stringent cleanliness standards as defined by the International Organization for Standardization (ISO). It is designed to maintain a maximum allowable particle concentration of no more than 3,520 particles per cubic meter for particles ≥0.5 micrometers in size.

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Cleanroom Project Scope(from structure, HVAC,electric to autoc ontrol)1. Cleanroom Structure: Wall Panel, Ceiling Panel, Windows, Doors, Fttings, Flooring
2. HVAC: AHU, Chiller, dehumidifier, Ducting, Piping, etc.
3. Electric: Lighting, Switch, Cables, Wires, Power Distribution Cabinet, etc
4. Auto- control: PLC Controller, Sensors for Humidity and Temperature, Control Panel
5. Process Piping System: Gas, Water Pipeline
EquipmentAir shower, Cargo shower, Mist shower, Dynamic pass box, Static pass box, Sampling booth,Weighing booth, Dispensing booth,
Medicine stability test chamber, isolator, VHP sterilizer,Biological safety chamber, FFU, LAF, etc.
Temperature21-27*C (or as per required)
Humidity30-60°C (or as per required)
ApplicationPharmaceutical factory, hospital, medical device factory, electronics factory, food factory,cosmetics factory, etc.
Qualification DocumentsCE GMP ISO
Full ServiceFAT and SAT Service, Professional Consultation, Training, 24 hours technical support

an ISO 5 modular cleanroom is essential for processes that require strict control of airborne particulate contamination to ensure product integrity and compliance with industry standards.


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Cleanrooms Airflow

The airflow principle in an ISO 5 modular cleanroom is critical for maintaining the required cleanliness levels and ensuring that the environment remains free from contamination. Here are the key aspects of the airflow principle in an ISO 5 cleanroom:

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Cleanrooms Installation

Cleanrooms Testing

Cleanroom testing is a series of tests performed on the interior environment of a cleanroom to verify that it meets specific cleanliness requirements. These tests usually involve the measurement of a number of parameters such as air cleanliness, temperature and humidity, air velocity and air volume, noise, illumination, etc. inside the clean room. The purpose of the testing is to ensure that the clean room is able to provide a stable and contamination-free environment during the production process.

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FAQ

What are the best practices for cleanroom entry?

Best practices for cleanroom entry include strict gowning procedures. This reduces the risk of contamination from personnel.

Personnel should also undergo air showers before entry. Limiting access to trained staff ensures a controlled environment.

How to manage cleanroom supplies?

Managing cleanroom supplies involves regular inventory assessments. This ensures that essential materials are always available.

Implement a tracking system for supplies to avoid shortages. Maintain a clean storage area to minimize contamination risks.

What are the methods for cleaning cleanroom surfaces?

Common methods for cleaning cleanroom surfaces include:

  1. Using lint-free wipes.
  2. Employing approved disinfectants.
  3. Following a specific cleaning protocol.

Regular cleaning schedules help maintain cleanliness and reduce contamination.

What are the key components of a modular cleanroom?

Key components of a modular cleanroom include:

  1. Wall panels for containment.
  2. Air handling units for ventilation.
  3. HEPA or ULPA filters for air cleanliness.
  4. Lighting systems designed for cleanroom standards.

These components ensure a controlled environment for sensitive processes.

What are the key features of a modular cleanroom?

Modular cleanrooms offer flexibility, allowing for quick assembly. They can be customized to meet specific industry requirements.

These cleanrooms are also designed for easy scalability. Their modular nature supports efficient layout adjustments as needs change.

What is the importance of cleanroom training?

Cleanroom training is essential for maintaining operational standards. It ensures that personnel understand contamination control procedures.

Regular training updates keep staff informed about best practices and compliance requirements. This ultimately enhances the cleanroom environment.

What types of industries use modular cleanrooms?

Modular cleanrooms are utilized across various industries, including:

  1. Pharmaceuticals
  2. Biotechnology
  3. Electronics
  4. Aerospace

These industries require controlled environments for sensitive processes and products.

How to conduct particle counts in a cleanroom?

To conduct particle counts, use a calibrated particle counter. Position the device according to cleanroom protocols for accurate readings.

Monitor air samples at specified intervals and locations. Analyze data to ensure compliance with cleanliness standards.

What are the applications of ISO 5 cleanrooms?

ISO 5 cleanrooms are used in several critical applications, including:

  1. Pharmaceutical manufacturing
  2. Semiconductor production
  3. Biotechnology research
  4. Medical device assembly

These applications require stringent contamination control for product integrity.

What are the common misconceptions about cleanrooms?

Common misconceptions about cleanrooms include:

  1. They are completely free of contaminants.
  2. Personnel do not need training.
  3. They are too expensive to maintain.

Understanding these misconceptions is crucial for effective cleanroom management.

How to evaluate cleanroom performance?

Evaluate cleanroom performance by monitoring key metrics regularly. This includes particle counts, temperature, and humidity levels.

Conduct routine audits to assess compliance with cleanliness standards. Use data to inform maintenance and operational improvements.

What are the design considerations for a modular cleanroom?

Design considerations for a modular cleanroom include:

  1. Cleanliness classification requirements.
  2. Space efficiency and workflow optimization.
  3. Integration of utilities and equipment.

Careful planning ensures a functional and compliant cleanroom environment.

How to document cleanroom procedures?

Document cleanroom procedures by clearly outlining each step. Use simple language and include diagrams when necessary.

Regularly review and update procedures to reflect current practices. Maintain a centralized location for easy access by personnel.

How to select the right modular cleanroom supplier?

To select the right modular cleanroom supplier, evaluate their experience in the industry. Check for compliance with relevant standards and certifications.

Request references and case studies to assess their capabilities. Compare pricing and support options for informed decision-making.

How to conduct a cleanroom risk assessment?

Conducting a cleanroom risk assessment involves identifying potential hazards. Evaluate the likelihood and impact of each risk.

Develop mitigation strategies to minimize identified risks. Regularly review and update the assessment as conditions change.

What is the significance of cleanroom airflow patterns?

Cleanroom airflow patterns are crucial for controlling contamination. Proper airflow prevents the accumulation of airborne particles.

Maintaining a unidirectional airflow helps ensure a consistent clean environment. Regular monitoring of airflow patterns is essential for compliance.

What is the life cycle of a modular cleanroom?

The life cycle of a modular cleanroom includes several stages:

  1. Design and planning.
  2. Installation and commissioning.
  3. Operation and maintenance.
  4. Decommissioning or reconfiguration.

Understanding this cycle aids in effective management and planning.

What are the cleaning protocols for ISO 5 cleanrooms?

Cleaning protocols for ISO 5 cleanrooms include:

  1. Using approved cleaning agents.
  2. Regularly scheduled surface cleaning.
  3. Employing proper techniques to minimize contamination.

Adhering to these protocols is essential for maintaining cleanliness.

What is the importance of airlocks in modular cleanrooms?

Airlocks are crucial in modular cleanrooms for controlling access. They prevent contamination by creating a barrier between clean and non
clean areas.

This ensures that any particles or contaminants do not enter the cleanroom during personnel or material transfer. Effective airlocks help maintain the integrity of the controlled environment.

How to achieve ISO 5 cleanliness?

Achieving ISO 5 cleanliness requires strict adherence to protocols. Implement stringent gowning procedures for all personnel entering the cleanroom.

Utilize high-efficiency air filters and maintain proper airflow patterns. Regular monitoring and cleaning schedules are essential to uphold cleanliness standards.


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