Introduction:

For a variety of solutions, various processes are carried out in the industry for removal of solvent to obtain the dry solute. Application of heat is the most commonly used and also the most economical and simple method.

For heat labile substances or where any physical ,chemical or enzymical changes are detrimental to theproduct & its application Lyophilization is the preferred drying process . Sublimation of frozen ice directly in the form of vapour under high vacuum is the basis of the lyophilization process.

Lyophilizer of IFD series has seven basic principles:
- Optimal flexibility in programming the recipe to suit a wide variety of products
- Components incorporated are from reputed international manufacturers having proven performance and dependability over years.
- Compliance to cGMP guidelines
- Accuracy, reliability and repeatability of process
- Adequate safety features and precautions
- Full range of documentation service
- Complete resting facilities before dispatch.

Constructional developments:

Drying Chamber:
- Designed for full vacuum and over pressure of 2.5 bar
- Features and finish to meet cGMP guidelines.
- Door has provision of view port and manual/automatic holding clamps.
- Additional view port for inspection from machine room.
- Precision machining of the shelves provides circuitous route for the fluid ensuring optimum heat transfer.
- Shelf stack placed in the center has flexible connections to in/out manifolds.
- Provision of hydraulic stoppering.

Ice Condensor:
- Designed for full vacuum and over pressure of 2.5 bar
- Features and finish to meet cGMP guidelines.
- Normally mounted externally with isolation valve
- Provided with view port
- Defrosting arrangement

Overall assembly:
- Mounted on skid. The components are arranged in such a way that servicing is easy.
- Insulation material suitable for ultra low as well as high temperature
- Gasket material suitable for operating temperature , pressure and vacuum range.
- With front facia ensuring isolation of sterile zone.
- Internals of drying chamber and condensor electro polished.

SUB SYSTEMS

Refrigeration:
- Designed for high energy efficiency using the world reknowned two stage, semi hermetic compressors.
- Environment friendly CFC free refrigerant.
- Fully protected with operational safety devices

Heat Transfer:
- Heating and cooling of shelves achieved using heat transfer fluid suitable for operating range of 70 deg C to 80 deg C
- Cooling of the fluid in PHE using refrigerant and heating using electric equipment
- Seal-less circulating pump suitable for operating range.

Vacuum System and Nitrogen balancing:
- 2 stage , rotary vane, oil sealed vacuum pump for achieving ultimate vacuum of 5 x 10 -3 mbar
- N2 balancing systems for controlling vacuum in the desired range.

CSP/SIP:
- To meet cGMP guidelines CIP/SIP systems are incorporated
- Elaborate documentation for validation compliances.

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Process:

In freeze drying process, solvent is removed from frozen material by converting it directly into vapour formwithout intermediate formation of liquid. The sublimedvapour is conveyed to a collector known as ice condenser/moisture trap. Heat is removed from the collector by means of a refrigeration system to condense this vapour into the form of ice.

The process of lyophilization can be classified into six phases :
- Freezing of the product and Freeze hold
- Cooling of the ice condensor
- Evacuation
- Primary drying
- Secondary drying
- Pressure equalization and Stoppering.

To have freedom for evolution of recipe which can suit a wide variety of products basic stages are sub divided into:
- Freezing - 3 segments
- Primary Drying - 10 segments
- Secondary Drying - 3 segments

Each segment has selectable as desired, ramp soak steps. Induction of additional segments when required.

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Automation and Control:

Our machine incorporates fully automatic PLC operation , complete with SCADA that can be custom made as per requirement.

The features that we offer are:
- Direct PT 100(temperature sensor) connection to the PLC
- Pressure analog module for mTor reading.
- Separate communication port (RS-232 BD) for SCADA Communication
- Separate parameter setting for each set point from Operator interface
- Continuous on line print during auto cycle
- Printing provision in manual mode.
- Separate data logging interval for each phase of machine cycle.
- 3 level password protection available

SCADA Features:
- Continuous data logging for automatic and manual mode .
- Parameter setting, recipe setting, process start stop from SCADA system.
- Alarm history and on -line alarm on SCADA package.
- MIMIC diagram
- Online alarm as well as alarm history for all utility Precondition and process alarms.
- Recipe setting for various products.
- All parameter setting from SCADA package.

The Automation system consists of the following:
- Versatile and Powerful pLC
- Custom made Supervisory Control and Data Acquisition software specially developed for Lyophilizer
- MMI as per features considered essential
- Programming and Analysis of process with the SCADA and/or MMI. Alarm function included.
- Live Mimic diagram on SCADA

Alphanumeric printer and strip chart recorder for batch records:
- Required number of probes for temperature, absolute pressure and gauge pressure.
- Backup option of manual and semi automatic operation.
- Necessary electrical switchgear and control included
- 3 level password security for viewing, changing set points and changing the sequence.

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Documentation and Validation:

On receipt of URS, the documentation service will take care of the following:
1. DQ
2. IQ
3. OQ

Validation will be undertaken on completion of OQ. Revalidation service available.

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