Quality assurance cleanroom starts with a recognized certificate for a validated space that an independent international party certifies complies with ISO 14644.
Why a certificate?
Why is certification so important? The procedures in a 14644 environment limit the occurrence of microscopic particulate matter that can disrupt the process, as well as be the carrier of microorganisms. In a Highcare, extra attention is paid to being able to reliably clean the areas, the cleanroom design is sanitary.
Inert and flush
Highcare applies inert materials that are sanitary and flush in design. This unique system meets the highest quality standards and is internationally recognized. All materials are proven suitable for use in this type of environment.
Quality assurance
A quality assurance system begins by establishing procedures internally before the cleanroom design is final and installation begins. This system is compiled and optimized by the users. It is a continuous process.
Validation and frequency
The maximum time interval between testing the airborne particle concentration of an ISO Class 5 cleanroom and below is six months and for ISO Class 6 and above is 12 months.
Demonstrated through a cleanroom certificate prepared by an independent party.
– Classification of air purity by particle concentration and ISO 14644-2: 2015
– Monitoring to provide evidence of cleanroom
– Performance with respect to air purity per particle concentration.
A cleanroom certificate should comply with the latest ISO.
Design and construction
Highcare designs and builds modern, state-of-the-art cleanrooms. The emphasis is on a functional working environment through optimal air technology. A Highcare cleanroom is composed of carefully selected materials that are suitable for a sterile environment and meet the highest cleanroom requirements. We deliver ready-to-use, turnkey, with ISO cleanroom certification. The walls and ceilings are composed of metal. Flammable products such as PIR, PUR or PS are not used.
Cleanroom requirements
The classification or cleanroom certificate is tailored to the use. For each sector and sub-sector, the rooms are validated according to specific rules. The basis is the ISO standardization, which is supplemented by these industry-specific requirements such as a quality assurance system. A cleanroom certificate is usually a snapshot and says little about the operating characteristics of the building system. For example, a Highcare cleanroom is remountable and relocatable. Rooms can be quickly adapted to changed production systems. Highcare builds turnkey: the cleanroom is delivered ready to use, but can easily be modified later.
ISO14644-1 5 – 8
ISO 14644=1 defines the maximum amount of suspended particles per m3. The number represents on a logarithmic scale the maximum number of 0.1μm particles that may be suspended in the air. In tabular form:
- At ISO 3, the air may contain 1,000 particles per m3
- At ISO 4, the air may contain 10,000 particles per m3
- At ISO 5, the air may contain 100,000 particles per m3
- At ISO 6, the air may contain 1,000,000 particles per m3
- At ISO 7, the air may contain 10,000,000 particles per m3
- At ISO 8, the air may contain 100,000,000 particles per m3
Ingenious airflow is one of the hallmarks of a Highcare cleanroom. Using a unique technique, purified air is blown in through the ceiling and extracted at plinth level. A Highcare cleanroom is flush constructed and washes a room clean with air, so to speak. The metal and glass walls are easy to clean (sanitary) and manufactured from materials that do not age (inert materials).
A sound technical installation guarantees a continuous flow of filtered air. Based on your process, determine cleanroom requirements by choosing a specific standard and classification. Commonly used classifications are ISO 6 or lower.
IFD system
Highcare Cleanrooms builds according to the IFD system. This is a modern construction technique, which guarantees Industrial quality. This is a demountable product with a flexible layout. Choosing Highcare Cleanrooms offers the assurance of a high classification through flush and sanitary finishing. The inert metal walls and ceilings are durable in use with a high economic lifetime.