Cleanroom standard

In general, the IS series of cleanroom standards support the GMP guidance of the regulatory authorities, but with one important exception air cleanliness classification for airborne particles. The air cleanliness classification scheme according to ISO 14644-1 is based on a coherent approach described by a mathematical formula (shown in the chapter Qualification of Water and Air Handling Systems, by K. Kawamura). 

International Cleanroom Standards, ISO 14644. Geneva, International Organization for Standardization. 

Cleanroom standard The US Federal Standard 209E, Airborne Particulate Cleanliness Classes in Clean-rooms and Clean Zones, is required for manufacturers who want to conform to quality system regulation. Via the industrial ISO European Community, it has been integrated with ISO. Among the more important recent changes are metrication, revision of upper confidence level (UCL) requirement, provisions for sequential sampling, and an alternative verification procedure based on determination of the concept of ultra-fine particles known as U descriptors. 

The purpose of open unidirectional airflow benches is to protect products from particulate contaminants by creating a controlled environment. These benches are used, for example, in electronic, biological, pharmaceutical, and food industries. It should be mentioned that within pharmaceutical production, aseptic sterile processes must be carried out in a Class 100 environment (U.S. Federal Standard 209 E, Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones). To avoid particle contamination in the bench, horizontal or vertical airflow with high-efficiency particulate air (HEPA)-filtered air is used. The air velocity is normally 0.4-0.5 ra s". Some examples of typical arrangements of open unidirectional airflow benches are shown in Fig. 10.51. 

Federal Standard 209E. Airborne Particulate Cleanliness Classes in Cleanroom and Clean Zone (Sept. 11, 1992). 

In 1990, the technical committee CEN/TC 243 Cleanroom Technology was established under the umbrella of CEN, the European Committee for Standardization (founded by EU and EFTA). In 1991, the ISO/TC 209 was inaugurated at the request of the American National Institute for Standardization (ANSI). 

Through an agreement in Vienna in 1991, CEN and ISO have cooperated in the following way. Since both technical committees targeted standardization of cleanroom specifications they were merged to form the committee ISO/TC 209, Cleanrooms and Associated Controlled Environments. Draft standards are submitted to ISO and CEN bodies at the same time. If approved by CEN, the standard will become a mandatory national standard of all the European states and existing conflicting requirements have to be withdrawn. If approved by ISO, the member states (outside Europe) can adopt the standard if they want to do so. 

Of the seven 14644 documents, three were issued by the end of 2001. The other four are in different stages of being drafted. In November of 2001, the United States decided to replace Federal Standard 209E with ISO 14644 Cleanrooms and Associated Controlled Environments Part 7 Classification of Air Cleanliness (ISO 14644-1) and Part 2 Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1 (ISO 14644-2). (See Table 6.)... 

Part 2 Specifications for Testing Cleanrooms EN/ISO 14644-2 2000 Published to Prove Continued Compliance Standard... 

Schicht, H. H. International Standards on Cleanroom Technology and Their Impact on the Pharmaceutical Industry—An Update. Parenteral Drug Association, Basel Congress (2002). 

IES (1992), Institute of Environmental Sciences, Federal Standard 209E, Airborne particulate cleanliness classes in cleanrooms and clean zones, Mount Prospect. Available at http //www.set3.com/papers/209e.pdf (accessed October 2006). 

NFPA 287 Standard Test Methods for Measurement of Flammability of Materials in Cleanrooms Using FPA... 

International Organization for Standardization (ISO) (2004), Cleanrooms and associated controlled environments—Part 7 Separative devices (clean air hoods, gloveboxes, isolators and mini-environments), ISO 14644-7. 

A. A major concern when working in a clean room is the generation of particles of the size that cannot be seen and spreading these particles throughout the clean room. Every possible precaution must be taken to contain these contaminants and protect the clean-room environment. Everything that is done as a standard operation must be analyzed to determine if it will adversely affect the cleanroom. If you have any concerns, ask the clean-room monitor before you damage the environment and incur unnecessary clean-up cost. 

The cleanroom facility should be carefully designed to control the ingress of contaminants, and be positively pressurized to the surrounding area in accordance with industry standards. The core and anterooms are positively pressurized by varying the amount of incoming make-up air. ° In the case of soft wall clean space facilities, such pressurization (potential outflow) is not possible, and a sufficient amount of constant, active outflow (kinetic outflow) should occur to prevent ingress of contaminants. 

Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones Federal Standard 209E Federal Supply Service, General Services Administration Washington, DC, 1998. 

The trend towards elimination of hydraulics in pharmaceutical process areas has turned maintenance over to the instrumentation and electrical specialists, as variable frequency drives become the standard. The Inverting Filter Centrifuge (Heinkel) eliminates all hydraulics from the centrifuge design to satisfy increasingly stringent cleanroom requirements by pharmaceutical companies. The risk of hydraulic oil in the process area has been a concern with respect to contamination with the product. 

The AFP step height repeatability is < 5A on a lpm step height standard. Total indicated runout (TIR) is <10nm for a 10mm profile. The noise floor in closed loop mode is - 4.5A RMS in a cleanroom with 76dBc acoustic noise. In open loop mode, under the same conditions, the noise floor is - 1.5 A RMS. 

In this Part of the Code, air quality is specified in terms of Australian Standard AS1386-1989 Cleanrooms and Clean Workstations. Reference should also be made to this Standard for guidance on clean space control and on the design, installation, operation and inspection of clean workstations and cleanrooms generally. 

Access to cleanrooms should be restricted to the minimum number of authorised personnel. Work practices should minimise traffic. Standard operating procedures for entering and leaving the controlled environment should be readily available and the subject of close supervision. 

In cleanroom suites in which both terminally sterilised and aseptically prepared products are made, it is preferable for both types of product to be processed in accordance with the standards required for aseptically prepared products. 

Items brought into cleanrooms, including means of transport, should be of a standard of cleanliness compatible with the environmental standard for the room. 

Clothing should be appropriate to the work zone environment in which the personnel will be working and should conform to Australian Standard 2013-1989 Cleanroom Garments. In addition to the requirements of the Standard and those of Clause 1208 -... 

In contrast to the above, there are cleamoom particle number concentration standards. Within the context of this review, the key point to consider is that particle number concentrations within cleanrooms are tightly regulated by virtue of the specific criteria with which they must comply to secure and maintain a given classification. This stands in great contrast to outdoor enviromnents worldwide. 

Furthermore, the standard processes can require some sophisticated instrumentation, particularly if located in costly cleanroom environments, some of which are not always readily accessible to the... 

ISO TC-209 certification An ISO technical committee that was established in 1993 to develop an international standard for cleanroom and associated controlled environments. Thirty-four countries are active with a target to... 

Clean Rooms Procedural standards for certified testing of cleanrooms... 

---