This course is designed to give participants an understanding of the requirements for qualification of a lyophilizer and validation of lyophilization processes. Since lyophilizer sterilization and sterilization of the nitrogen system used to backfill require separate validation, media fills should primarily validate the filling, . With Lyophilizers and Freeze Dryer validation, it is essential to verify that the system can meet and control to the different temperature.

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Lyophilizer/Freeze Dryer Validation

Get the latest articles from Pharmaceutical Online delivered to your inbox. When the product temperature equals the shelf temperature, it can be inferred that primary drying is complete.

This course is designed lyophiliizer give participants an understanding of the requirements for qualification of a lyophilizer and validation of lyophilization processes. When this pressure rise approaches zero, no more vxlidation vapor is being generated via sublimation.

Historically, validation of the lyophilization process focused on demonstrating three consecutive successful batches conducted in the commercial scale manufacturing operation.

Lyophilization Validation – Pharma Applications

This critical temperature determines the maximum temperature that the product can withstand during primary drying without it melting or collapsing. Ellab offers a battery package that, when paired with an appropriate logger, can operate at low temperatures. Stoppering arms must be verified as acting uniformly on all product containers.

Barb Berglund has been working in the pharmaceutical industry, specifically with sterile parenteral dugs, for over 15 years. The ISO standard describes Aseptic processing of healthcare products in regards to Lyophilization. Choosing a control system for the freeze dryer depends on the application and use i.


This certificate can be submitted as verification of completion to the Board for license renewal. It is not recommended to arbitrarily and repetitively increase the shelf temperature during primary drying, as is seen on some older legacy cycles.

Shelf temperature accuracy and uniformity testing. With simple manifold freeze dryers, the product is placed in a vial or flask depending on quantity, and then frozen in a separate piece of equipment. I know these machines very well indeed. Personnel from all levels involved in manufacturing, validation, and quality aspects of the lyophilization process will benefit from this course.

The drying portion of freeze drying is actually a two part process consisting of Primary Drying and Secondary Drying. At the end of primary drying when all of the free ice crystals have been sublimed, the product will appear to be dried. Lyophilized products are extremely hydroscopic and they must be sealed in air tight containers following freeze drying to prevent rehydration from atmospheric exposure.

Karen Bossert discusses process validation part 1. Heating rates are for information only.

Operational Qualification In addition to the common requirements outlined in the “General” section, the OQ protocol will outline the following tests. Flowers Animals Water damaged books validwtion documents. This is critical to product quality.

This heat input does not melt the product because an equivalent lyophiizer of heat is removed by vaporization of the solvent.

The refrigeration system must be able to maintain the temperature of the condenser substantially below the temperature of the product. PDA will not allow persons to attend a course without payment, or guarantee of payment.


Because product will dry from the top down, the tip of the thermocouple should always be placed at the very bottom and center of the container. In most cases, the more dry the product, the longer its shelf life will be. There are essentially two categories of freeze-dryers: Please be sure to bring your confirmation letter as proof of registration.

I agree to the Terms and Privacy Statement. In a clean room environment with very few particulates for ice nucleation, there is a significantly greater amount of super-cooling. Larger ice crystals improve the speed of the freeze drying process because of the larger vapor pathways left behind in the dried valiration of the product as the ice crystals are sublimated.

Several analytical methods are available for validatin that primary drying is complete. Request a Quote Interested in learning more about our products? The usual number of temperature measuring points during process monitoring could be as high as one sensor placed in a representative sample vial or tray per shelf.

By removing the water from the material and sealing the material in a vial, the material can be easily stored, shipped, and later reconstituted to its original form for injection. This website uses cookies to improve your experience.