DMH Series 100grade Purifying Split-door Drying

Product Application

This series of products are mainly used for drying, sterilizing and pyrogen-removing the heat resistant articles such as penicillin bottles, 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

 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)

The advanced technology can realize the dynamic 100-grade and superior temperature uniformity for the dry-heat sterilization ovens

* The machine-operated door adopts pneumatic open/close system which is safe and stabilized

* The machine-operated door adopts advanced vacuum-sealing method to ensure good seal, easy and practical operation of the door, effectively preventing the sterilized articles from being polluted.

* The H13-grade high temperature resistant high-efficiency filters are installed on all the air intake system, outlet system and cavity, and the filtering efficiency can reach 99.99% to ensure 100-grade in the cavity.

* The primary filter of cavity adopts innovative combination sealing technology¹, to make the removal and repair easy while improving the product efficiency.

* The laminar board in the cavity adopts special pore distribution to control the level laminar air, so that the heat energy utilization rate and temperature uniformity are improved effectively.

* The equipment adopts advanced full automatic control system, therefore the temperature is controlled automatically and the positive pressure is obtained automatically in the inner cavity.

* The separate over temperature protection system can secure the equipment effectively.

* This product reserves the multi-function verification port and can perform the 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 is possible to contact the article adopts the imported 316L stainless steel material.

* The outer surface adopts the imported 304 stainless steel material, and a new manufacturing technology is used to comply with GMP requirement and make the appearance more simple and beautiful.

* The special heat-insulating type is used to ensure the appearance temperature of products ≤ room temperature +15℃.

* The inner cavity room is welded well by adopting TIG welding technology, the four corners of inner cavity adopt arc transition structure, and they can be cleaned easily without dead corner.

Note: 1. if you want to know about the specific sealing type and working principle for the high temperature resistant high-efficiency filter of cavity, please contact us.