wfi and STEAM STERILIZER

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 All pharmaceutical production processes require a stable & consistent supply of quality controlled water for applications ranging from non-critical processes to product formulation. The most important equipment in any pharmaceutical plant manufacturing injectable solutions is the WFI Still. Our WFI Still produces distillate that meets the current U.S and European pharmacopeia for Water for Injection guidelines systems equipped with a range of features to ensure that your installation and qualification is quick & trouble-tree and that your WFI production remains efficient and reliable.
WFI Still is designed with efficiency in mind. Since the system recovers the latent heat of vaporization occurring within its own process to heat feed water and uses the feed water as the primary source of cooling, our system is an energy and money saving ingenuity. 

MULTI-COLUMN DISTILLATION PLANT

Distillation is the primary process used for the production of USP Water for

Injection for pharmaceutical applications.

o As the name suggests, MCDP consists of individual pressure vessels (single columns)

assembled in series.

o Multi-Column Distillation Plants (MCDP) are designed to produce

pyrogen/endotoxin free water conforming to IP/BP/EP/USP standard.

o These individual columns are designed , constructed and tested as per the American Society of Mechanical Engineers (ASME, Section VIII, Division 1- Unfired Pressure Vessels) since they operate at pressures as high as 6 to 10 bar.

o Plants are available from 50 Liters/hour to 10000 Liters/hour.

o WFI-Combo design optimizes the Control Panel by combining the panel for WFI

Generation and Distribution system.

Special Features

• All Evaporator (columns) sheets and tubes as well as all surfaces in contact with Pure Steam or distillate are constructed of 316L stainless steel with inside electropolished and Teflon gaskets.
•  All tubes joints are Orbital welded and qualified with videoscopy,
• Fully-Automatic PLC based Control Panel System with auto sanitization and printing facility.
• First column equipped with Double tube sheet as a provision to avoid boiler steam mixing with Purified water.
• Pure steam generation port.
• Complete documentation to meet and exceed international audit requirements.

 The production programs in the pharmaceutical industry are aimed at maximum safety, top quality and high economy. This applies in particular to the sterilization process. Steam Sterilizer continues to be one of the ancient but widely used sterilization techniques in the Life-Science & HealthCare Industry. The process systems now have to meet the most exacting demands for temperature and pressure / Vacuum control and process documentation. A sterilization systems represents Therefore,  takes measures to ensure that our Sterilizers provide and life cycle economy. Every Sterilizer is produced to your specifications and needs. Flexible options allow selection of the right equipment for each specific sterilization load and packaging.

Application

• Solid materials.
• Porous materials like garments, fabrics, etc.
• Closures, Vessels, Machine and change parts.
• Empty Glassware, Utensils, Instruments.
• Solutions in glass ampoules, vials & bottles.
• Filters and respective accessories.

 Features

• Chamber with sloping bottom & recessed drain connector for effective condensate removal.
• Three designs of jacket- Straight profile, u-profile and dimple for different applications.
• Machine gasket groove formed on CNC machine for superior gasket performance.
• Double stage vacuum pump with unique water safer arrangement.
• Dynamic steam and vacuum programs for short equilibration time and excellent temperature uniformity.
• Air detector device meets requirements of EN285.
• Comprehensive safety features for operator and product safety.
• Hot air drying in combination with vacuum for best drying results.

 The Vertical Autoclave is effective for Sterilization and Decontamination in a Laboratory, Research Center or Testing Facility. The system is designed to perform gravity displacement sterilization cycles and can be optionally fitted with a vacuum system to perform pre-vacuum sterilization cycles thereby offering maximum flexibility to the user. The system is controlled by a PLC and is provided with a user-friendly operator terminal. Wide range of options are available for batch documentation, which comply with the recent regulatory requirements. 

 Application

• Liquids such as nutrient media and buffer solutions
• Solid items such as pipettes, tubes and filters
• Glassware
• Biohazard sterilization

 Feature

• Flexible range of models for different user requirements.
• Automatic locking an unlocking of door for high safety.
• Steam generation outside chamber for best results.
• Baskets for ergonomic loading and unloading.
• High precision control system for perfect sterilization results.
• Password protection allows for secure access control.
• Independent temperature and pressure monitoring.
• Cycle information recovery in the case of power failure or cycle interruption.
• Fail Alert – Indicates cycle failure or interruption.
• Door Alert – Indicates the door is unlocked.
• The laboratory line can be supplied with a built-in printer to document the performed cycle

 A pure steam generation system is a specialized setup designed to produce steam that meets high purity standards, typically used by pharmaceutical, biotechnology, and food processing industries. It ensures that the steam is free from impurities and contaminants, making it suitable for critical processes such as sterilization and cleaning (CIP/SIP) in these industries. The system often involves the use of multiple stages, including pre-treatment, evaporation, and superheating, to remove impurities and produce steam with a high degree of purity.

• Komal’s Pure Steam Generator is a packaged skid-mounted unit incorporating all necessary controls and functions to produce Pure steam as per the latest IP/BP/USP standards. Plants are available from 50 kgs/hr to 2000 Kgs/hr.
• These generators are used for the Sterilization of vessels, Sterilization of Distribution systems, Autoclaves, reactors, and also humidification of sterile areas.

• Full-automatic PLC-based Control Panel System with auto sanitization and printing facility.
• The First column is equipped with a Double tube sheet as a part of the provision to avoid boiler steam mixing with purified water.
• All Contacts parts are SS316L with internally electropolished < 0.5Ra.
• The piping system is orbital welded and qualified using the videoscopy procedure. 
• Complete documentation to meet and exceed international audit requirements.