ISO 4, 5, 6, 7 & 8 CLEANROOMS

Cleanrooms are microparticle-free rooms that are used in a variety of fields, including the Life Sciences, Pharmaceutical, Biological, Medical Device, Food Technology, Nanotechnology, Photonics and the many forms within the Electronics Industries.

1    Pharmaceutical Cleanrooms:

Life Sciences or Pharmaceutical or the short form “Pharma”, is used to cover a wide range of applications within the industry that provides us with the tools to live our lives better.

As such the Cleanrooms are not designed to control particles for the damage they will cause by failure such as in Electronics, but as a means of controlling the bacteria, which uses the particles as a host.

Electronics failure in a computer chip, will not typically have a life ending consequence, however in the medicines we use this can be the case.

The closer to injection to our bodies the higher the standards are for control of Microbial Contamination, such as in Injectable Antibiotics, where they are processed and shipped in vials after being filled in a Aseptic Vial Filling manner or directly in Syringes

These Filling areas are under Laminar Flow and 100% HEPA Filtration to insure no contamination is present, which are ISO 4 (Fed Std. 209E Class 10), also known as Grade A.

Pharmaceutical standards can overlap into other related industries such as Nutraceuticals, Biotechnology, and Medical Devices

2        Pharmacy Cleanroom:

Pharmacies are increasingly upgrading their standards to match the requirements of USP797.

There is confusion as to how this standard applies to a Pharmacy.

Most of the decisions are based on the volume, and the drugs to be formulated.

Compounding will typically be performed in a Laminar Airflow Hood and as the hazard level increases, next would be a recirculating Bio Safety Cabinet, and then a Vented Bio Safety Cabinet, for example when you are formulating Chemotherapy Treatments.

3          PRINTED CIRCUIT BOARD CLEANROOMS

As technology advances, the volume of electronic devices become smaller and smaller space, increasing density of electronic components, PCB wiring density is increasing

Printed Circuit Boards are typically manufactured in ISO 7 or 8 Cleanrooms with attention to the consistent temperature humidity control.

The Cleanroom is used to reduce contamination between the line width of the circuit boards, the smaller the line width and spacing, the more particles can cause failure.

As most films used in the manufacturing of multilayer circuits are hydroscopic, printing them at a consistent temperature and humidity so that the layers align properly.

4          TRACE METALS CLEANROOMS

Accurate chemical analysis of inorganic elements and their species at ultra-trace concentrations is essential for understanding and modeling environmental systems and determining health effects.

In order to maintain sample integrity and prevent contamination during sample preparation or analysis, a high purity cleanroom or clean zone is required. Proper design, construction, use, and maintenance of a trace element clean room are necessary to achieve a high cleanliness environment, but guidelines and protocols specific to trace element cleanrooms are not available in federal or international cleanroom standards or in published literature.

Several design options are possible depending on technical factors such as the elements being analyzed and the sample preparation and analysis methods used, and non-technical factors such as the number of samples and analysts

5          Electronics Cleanrooms

Electronics Cleanrooms are used in the production of Printed Circuit Boards, Fibre Optics, and Assembly of Components

A cleanroom is a controlled environment where products are manufactured. It is a room in which the concentration of airborne particles is controlled to specific limits. Eliminating sub-micron airborne contamination is really a process of control. People, process, facilities and equipment generate these contaminants. They must be continually removed from the air. The level to which these particles need to be removed depends upon the standards required. ISO 14644 is the document that establishes standard classes of air cleanliness for airborne particulate levels in cleanrooms and clean zones. Strict rules and procedures are followed to prevent contamination of the product.

The only way to control contamination is to control the total environment. Air flow rates and direction, pressurization, temperature, humidity and specialized filtration all need to be tightly controlled. And the sources of these particles need to controlled or eliminated whenever possible. There is more to a clean room than air filters. Cleanrooms are planned and manufactured using strict protocol and methods.

6        Optics Cleanrooms

Optics Cleanrooms are used in the manufacture of high-quality lenses for Cameras.

Closely related to Electronics, the same considerations, of Particle Contamination. Temperature Humidity Control and Vibration Isolation apply.

Typically ISO 5 to 7 Cleanrooms, with the critical work performed under Laminar Flow ISO 4 Benches.

7          EDUCATION & RESEARCH LABS & CLEANROOMS

Educational & Research Cleanrooms are typically held to the guiding principle of remove variables.

The Cleanrooms are there to reduce contamination, and cross-contamination possibilities, temperature and humidity control must be constant.

We have built facilities for Electronics, Nanotechnology, Trace Metals Analysis. Photonics, Printed Circuit Boards

8         CLEANROOM DESIGN

There are many decisions to be made in building a Cleanroom, we will talk briefly about the major decisions, and how these decisions will affect your Cleanroom cost initially and operationally.

To better understand these decisions we are available to discuss this in further detail.

Please contact us so that we may have an open discussion about which options may be the best solutions for your project.

9        Components of Cleanrooms:

• Cleanroom Air Handling Unit
• Cleaning Materials
• Cleanroom Air shower
• Cleanroom Ceiling System
• Cleanrooms change room options
• Cleanroom commissioning and Qualification
• Cleanroom Doors
• Cleanroom Filtration
• Cleanroom Facility Management
• Cleanroom Electrical
• Cleanroom Material Passthrough
• Cleanroom validation
• Cleanroom communication
• HEPA workstations
• Fire suppression
• Cleanroom walls