ONCOLOGY GENERAL OSD LINE

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 Custom designed isolators for dispensing and/or sampling from various containers such as bags and drums into intermediate packaging or for direct charging into process equipment. These systems offer high containment and a controlled environment offering fast cleaning and drying features allowing for swift product changes.

Depending on the type of incoming packaging, the systems can be equipped with an airlock, a Rapid Transfer Port (RTP) or a drum docking system for material entry.

Dispensing and/or sampling isolators can be equipped with multi-scale systems including data acquisition and possible connection to an MES system for recipes management.

Other equipment such a sieves or mills can be integrated depending on the process requirements.

The isolators can be either equipped with a lower chamber for drum or liner charging, a split or SafeDock Valve for charging into an intermediate receiver or a hopper for powder conveying by Powder Transfer Syste  to actively charge a reactor, an IBC or a blender.

Containment solutions for tablet compression cover the spectrum from charging formulation into the tablet compression machine to metal detection for potent OEB 4 or OEB5 products. Any dust generated during the process is contained within the isolator to safeguard the operator and the environment. The ergonomically built negative pressure chamber safely contains the products during processing with glove ports for easy access. Material is transferred safely in and out of the isolator through the pass box or antechamber.
Tablet compression machine is integrated with the isolator. Split Butterfly Valve dispenses tablets into IBC bins or polybags. Integrate with processing equipment for optimal performance and safety. 

 Automatic Capsule Filling lines/machines with isolator are the latest in technology in Capsule Filling suitable for Containment applications. The complete line can be fitted in a single isolator chamber with Wash-In-Place thus ensuring continuous process flow up to collection of the final capsules and ensuring compliance to the required OEL levels.

Salient Features

• Complete line fitted in a single isolator chamber thus complying to required OEL levels.
• WIP compatible
• Main Drive is Servo driven with “No Capsule No Powder” feature
• Special Seals provided in working zone to prevent leakage into the drive zone
• Filtration of up to 0.2 microns for air and vacuum to ensure minimum exposure of product to external environment
• PLC system with HMI.
• 21CFR Part 11 Compliance can be provided
• Fill weight adjustment within seconds.
• Tamping Mechanism enables capsules to be filled with a weight variation of ± 2 %.
• Faulty capsule and filled capsule ejection stations with individual air controls.
• Special purpose gauges are provided for quick and easy change over.

 A blister machine isolator is a barrier that keeps the operator safe and the environment hygienic while they work with a blister packing machine. Isolators can be designed to meet specific needs, such as for the pharmaceutical industry, and can include features like:  

• Gas barrier protection: An inflatable seal strip and gas barrier protection keep dust from leaking out of the cabin.  
• Integrated workstation equipment: Some isolators include integrated workstation equipment.  
• OEB5 containment: Some isolators are designed to provide a maximum level of protection.  

 Complete granulation lines for small batch production, mounted under isolator in high containment OEB 5. A line can be composed by a high shear mixer, fluid bed dryer (12-bar pressure resistant construction) , cone mill to calibrate dry or wet products, possible kit for the transfer of the powder by vacuum, a washing and drying system. All systems have been designed to ensure maximum operator protection, during handling operations of  products with high level of toxicity. The equipment are fully customizable based on client requests.

Salient Features

• Complete Granulation line consisting of Sifter, RMG, FBD, Conemill and Blending fitted in a single isolator chamber thus complying to required OEL levels.
• Varying batch Capacities ranging from 1 kg to 15 kg can be manufactured depending on customer requirement
• WIP compatible
• Special Seals provided in working zone to prevent leakage outside the Isolator
• Filtration of upto 0.3 microns for air to ensure minimum exposure of product to external environment
• PLC system with HMI.
• 21CFR Part 11 Compliance can be provided

This is Negative Pressure Isolator, based on the nature of the product. This is usually placed in the QC area & is used for intermediate Quality Testing during Manufacturing. 

Special Features

• In-House manufacturing capabilities for equipment's & isolators.
• Customization of products as per customer need.
• 12" inch HMI screen
• 21  CFR compliant.