Dry Heat Sterilizer (DMH)
Min. Order / Reference FOB Price: US $500-99,000/ set
| Type: | Sterilizer |
| Finished Dosage Form: | Vials |
| Precision: | High Precision |
| Certification: | GMP |
| Voltage: | Customized |
| Computerized: | Computerized |
| Basic Info | |
| Model NO.: | DMH |
| Condition: | New |
| Brand Name: | Unimach |
| Transport Package: | Wooden Case |
| Origin: | China |
| Trademark: | UNMIACH |
| Customized: | Customized |
| Warranty: | 1 Year |
| Product Description: |
| Applications: |
| This series of products are mainly used for drying,sterilizing and pyrogen-removing the heat resistant articles such as penicillinvialss, aluminum caps, metal and glass vessels in the pharmaceutical industry. |
| Equipment and document system should comply with the standards: |
| CGMP regulation Pharmacopoeia of the People's Republic of China (2010 version) Good Manufacture Practice (2009) EU GMP Guide in Appendix 1, 11 and 15 FDA, Code of Federal Regulation (CFR) 21, Part 11: Electronic Record,Electronic Signature Good Automated Manufacturing Practice (5th version)/comply with GMP5 ISO14644-1 (For Cleanliness Class) ISO14644-3 (For HEPA integrity testing) |
| Technical Characteristics: |
| The advanced technology can realize the dynamic100-grade and superior temperature uniformity for the dry-heat sterilizationovens * The machine-operated door adopts pneumatic open/close system which is safeand stabilized * The machine-operated door adopts advanced vacuum-sealing method to ensuregood seal, easy and practical operation of the door, effectively preventing thesterilized articles from being polluted. * The H13-grade high temperature resistant high-efficiency filters areinstalled on all the air intake system, outlet system and cavity, and thefiltering efficiency can reach 99.99% to ensure 100-grade in the cavity. * The primary filter of cavity adopts innovative combination sealingtechnology, to make the removal and repair easy while improving the productefficiency. * The laminar board in the cavity adopts special pore distribution to controlthe level laminar air, so that the heat energy utilization rate and temperatureuniformity are improved effectively. * The equipment adopts advanced full automatic control system, therefore thetemperature is controlled automatically and the positive pressure is obtainedautomatically in the inner cavity. * The separate over temperature protection system can secure the equipmenteffectively. * This product reserves the multi-function verification port and can performthe dust particle verification test and temperature distribution test. * The primary filter of cavity has a DOP verification port. * The various cooling type can improve the work efficiency. |
| Construction Characteristics |
| * All the inner portion of the cavity which ispossible to contact the article adopts the imported 316L stainless steelmaterial. * The outer surface adopts the imported 304 stainless steel material, and a newmanufacturing technology is used to comply with GMP requirement and make theappearance more simple and beautiful. * The special heat-insulating type is used to ensure the appearance temperatureof products ≤ Room temperature +15 centigrade. * The inner cavity room is welded well by adopting TIG welding technology, thefour corners of inner cavity adopt arc transition structure, and they can becleaned easily without dead corner. |
