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滅菌システム

カテゴリ：生産ラインの医薬品

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説明

脈動真空蒸気滅菌器

主に、ガラスまたは金属容器およびトレイ（バイアル、ステンレス鋼バレル、凍結乾燥プレート、ラボデーとカプセル、その他の熱抵抗製品の滅菌に使用されます。特性：

Unique sealing design ,avoids leakage risk Pure steam diffusion panel design of the chamber, quality control ofcondense distributary and steam sterilizing.And coupled withextensive testing and validation of hydrophobic throttle orifice platejoint design, the sterilization efficiency is higher and the effect isbetter Flangeinside the chamber adopts overall processing technologywithout residual stress and advanced control of the sealing surfaceand sealing groove size during the manufacturing process lo assuregreater safety and reliability of the sealing during the deviceoperating and thus service life of the sealing ring is Automatic detection control of the pressure and temperature insidethe chamber and gate with insulation structure to improve thedistribution of temperature. High density ceramicinsulation material of the equipment, noparticles and outer covering stiffener stainless steel.

検証サービス：

BD(Bowie Dick) test Air tight test(leakage test in vacuum state) Empty load heat distribution test Full load heat distribution and penetration test Microbe challenge test Sterile filter integrity test

乾燥滅菌剤100クラス

この一連の製品は、主に、製薬産業における耐熱物質、アルミニウムキャップ、ステンレス鋼の金属、ガラスセーセルなどの耐熱物質のピロゲンの乾燥、滅菌、除去に使用されます。特性

All parts in the clean chamber those are in contact with the being processed articles are made of high quality The outer layer of the equipment is a full coverage design of high quality 304 stainless steel. The coating layer adopts a new manufacturing process without screw holes, which brings a simple and good outlook and is easy to clean without dead zones of pollution. The unique technique of vacuum negative pressure sealing is applied to the overall equipment, which greatly reduces the risk of product contamination Technique of one-way laminar flow in the processing regions makes the more uniform of temperature distribution and the more accurate of velocity and pressure control. TlG welding applied to the sterilization chamber, circular arcs design with great circle arc and the unique guide structure of stratified themal insulation guarantee the equipment performance of high quality.

検証とサービス

Validation of the cleanliness Online detection of dust particles HEPA tests of integrity and PAO test Validation of single directional flow Validation of temperature distribution

製造および品質保証処理機能CNC machining center Robot auto welding Polishing machine Assembly workshop Warehouse management TOP workshop Boroscope Surfaceroughnessdetector Material test

検証とドキュメント As Critical utilities of pharmaceutical factories, follow V modelfrom planning to running. Documentsmeet validation requirement, auto control can meet GAMP

サービスサポート Rich project management experience Strong project management team, Strong and professional talent pool Overall solution design as peruser’srequirement Consulting for overall solution of user’s factory Free technical training from experts Re -optimization design adjustment for customer required product Operator training, guidance Installation, commissioning and site training 24 -hours consulting service Convenient and quick on -site service Equipment and technology upgrading service