Q: What does it mean that HJClean particle counter supports optional ISO / GMP / 209E multi-standards? What are the advantages?
A: This specification means that HJClean particle counter is preloaded with 3 sets of cleanroom classification templates. You may select the corresponding specification before testing. The instrument will automatically calculate the cleanliness class and 95% UCL upper confidence limit, and match the corresponding limits according to the selected standard.
Q: What does it mean that HJClean particle counter supports optional ISO / GMP / 209E multi
standards? What are the advantages?
A: This specification means that HJClean particle counter is preloaded with 3 sets of cleanroom classification templates. You may select the corresponding specification before testing. The instrument will automatically calculate the cleanliness class and 95% UCL upper confidence limit, and match the corresponding limits according to the selected standard.Application scenarios for each standard:
1. ISO (ISO14644-1): Globally recognized cleanroom standard with counting unit pc/m³. Preferred for export projects, electronics and medical device clean workshops.
2. GMP (China GMP / EU GMP Annex 1): Dedicated standard for pharmaceutical sterile industry with Class A/B/C/D classification. Applied for clean zone validation, GMP audit and workshop acceptance in pharmaceutical plants.
3. 209E (FED-STD-209E US Federal Standard): Traditional classic US standard with unit pc/ft³, known for Class 100, Class 10000 ratings. This standard has been obsoleted, yet still adopted by overseas legacy factories and some semiconductor clients.
Core advantages
1. One device for multiple industries to meet diverse acceptance requirements This single instrument covers pharmaceutical, electronics and export projects. Select GMP for pharmaceutical customers, ISO for foreign trade projects, and 209E for some overseas old factories, with no need to change equipment.
2. Automatic calculation reduces risks of errors in validation reports After standard selection, the instrument automatically matches limit values, calculates the 95% UCL upper confidence limit and judges cleanroom pass/fail status. Manual table lookup and unit conversion are eliminated, and the generated data can be directly used for cleanroom validation reports.
3. Compliant with URS, bidding and third-party testing requirements For cleanroom project bidding, client URS requirements and third-party inspection acceptance, the adopted test standard can be clearly marked on reports, satisfying GMP audits and overseas client reviews.
4. Automatic unit switching The instrument switches counting units automatically upon standard change: pc/m³ for ISO/GMP, and pc/ft³ for 209E, preventing judgment mistakes caused by manual conversion.
Note: FED-STD-209E has been officially revoked. ISO14644 or GMP is recommended for new cleanroom projects. 209E is reserved only for compatibility to accommodate legacy projects and customary usage of overseas customers.