选择字体大小: 小 中 大

 

 

 

 

 

 

 

生物污染控制ISO14644国际标准

洁净室和相关受控标准

文件	名称	状态
ISO14644-1	空气洁净分类 （Classification of air cleanliness）	（ST）
ISO14644-2	证明连续符合14644-1标准的测试和监测技术条件(Specifcations for testing and monitoring to prove continued compliance with 14644-1)	（ST）
ISO14644-3	计量与测试方法 (Metrology and test methods)	（ADIS）
ISO14644-4	设计、建造和启动 (Design, construction and start-up)	（ST）
ISO14644-5	运行 (Operations)	（DIS）
ISO14644-6	术语和定义 (Terms and definitions)	（PS）
ISO14644-7	隔离屏障（Separative Enclosures）	（DIS）
ISO14644-8	分子污染 (Molecular contamination)	（PS）

 

洁净工艺生产过程中洁净工艺介质（待定）的分级标准

文件	名称	状态
ISO14644-9	洁净化学品（液体） Clean chemicals (liquids	（MS）
ISO14644-10	洁净水 Clean Water	（MS）
ISO14644-11	洁净气体 Clean gases	（MS）
ISO14644-12	洁净表面 Clean Surface	（MS）

ISO 14644 Part 1.
Part 1 of the new set introduces yet another system of numbering for particulate levels in air. This system, however, will certainly become truly universal and is a big step forward. It uses the integers 1-9 for classes that will cover all anticipated environments, though fractional numbers are possible.
Current pharmaceutical and device environments are commonly in the ISO range class 5 to class 8. Class 5- the old AS 3.5 (or US 100) has less than 3500 particles of 0.5 per cubic metre. Thus, using the very crude ratio of 10,000 particles per bacterium, we could have only one bacterium per cubic metre: very appropriate for aseptic filling.
Some microelectronic applications already go several classes lower and atom-by-atom applications now under development will, no doubt, use even class 1- less than 10 particles of size 0.1 microns per cubic metre! This starts to sound like the Andromeda galaxy where there are only a few hundred atoms per cubic metre.
The highest class recognised is class 9, corresponding to an (old) AS 35,000 if such a class had existed. For reference, the old GMP non-existent "Class 7000" that might have been delivered by the prescribed filters would be 8.2 on the new system.
The new Part 1 also introduces rules for sampling that must be mastered.
ISO14644 Part 2.
Part 2- compliance- deals with re-testing of installed cleanrooms and environments. This is a "true" standard as it sets out parameters that can be measured and certified. The new joint standard is tighter than the ISO original.
ISO1464 Part 3.
The third part- metrology- sets out test methods, but these are only "recommended"- the user may choose. This part has much useful data and there is no conflict with present AS 1807 methods. However, although the ISO Part 3 methods are intended as reference methods, do not discard your 1807 file as some of these methods may have continuing applications. Annex B1 is how to collect particles and Annex C1 is how to check the performance of the counter.
ISO1444 Part 4.
This part deals with design, which is where the revolution starts. Seventeen requirements for the cleanroom must be agreed between purchaser and supplier. Then there are 15 steps to be followed in planning, 3 in design, 9 in construction, 4 for monitoring, 15 for maintenance and 4 for training. One wonders if a certificate of compliance will ever issue, but the real revolution lies in the 15 initial steps: no longer can the purchaser rest on compliance with a prescriptive standard: he or she must now become familiar with all the necessary requirements. Even divesting the task to a really expert consultant will not be an escape hatch, as the consultant will still have to ask key questions and get decisions. Certification may also prove a rare event.
ISO14644 Part 5.
This Part deals with operation of the cleanroom. It mostly specifies the systems that must be in place, so certification is a higher possibility than with Part 4. Part 5 is in fact a marvelous textbook of cleanroom operation. One could almost add a company name at the top and christen it an SOP.
ISO14644 Part 6.
This part sets out definitions which, surprisingly, considering the fractured English that often emerges from European collectives, are very reasonable. Manufacturers might consider harmonising their internal definitions with them in due course.
ISO14644 Part 7.
Part 7 deals with a continuum of special environments, ranging from open to totally closed systems, separated from the atmosphere at large to various extents and by various means. It has over 40 items of requirements and is probably the least valuable of all the set. Many of the requirements may be "considered" rather than "met" and there are many "appropriates", reminiscent of the new EU/PICS-derived code of GMP.