LYOPHILIZER QUALIFICATION PDF

Lyophilization or freeze drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change. For composing validation protocol of lyophilizer need to carry out its qualification test and. decide acceptance criteria. So during selection of. Hi all, I have a question regarding an OQ of a freeze dryer. Im Validation Manager in a medium size medical devices company and have the.

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Typically, vacuum levels for freeze drying are between 50mTorr and mTorr with mTorr to mTorr lyophioizer the most common range. This heat input does not melt the product because an equivalent amount of heat is removed by vaporization of the solvent.

When the vacuum level set point is deeper than the vapor pressure of ice at the current product temperature, sublimation can take place. If renting bendable units, then they can be qualificahion in our dry block temperature baths.

Shelf temperature accuracy and uniformity testing. Shelf freeze dryers allow the precise control of lyohilizer rates which affects product freezing rates and crystal size. Standard Y fitting with extra port to allow 2 feedthroughs and 1 pressure sensor connected.

A suitable container system must be chosen for the product. This allows the vials to rest directly on the shelf and increases the heat transfer to the product. Product chambers are typically either a manifold with attached flasks, or, a larger chamber with a system of shelves on which to place the product. Typically, there are multiple steps involved for both freezing and drying of the product.

Vacuum is maintained in vials. The product temperature is dependant on the vapor pressure at the ice interface and in turn, this vapor pressure is dependant on both the rate of heat transfer into the product which is controlled by adjusting the shelf temperature and the system vacuum level set point. Each specific product or formulation that is lyophilized requires the development of a qualofication drying process that is based on the unique lyophilizr of the product, the amount of product and the container used.

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Operation Qualification for Lyophilization

In most cases, the more dry the product, the longer its shelf life will be. Operational Qualification In addition to the common requirements outlined in the “General” section, the OQ protocol will outline the following tests.

Bacillus stearothermophilus biological indicators are such that the product of the ‘D’ value and the log of the population is at least 6 e. It is best not to freeze a large block of sample in the bottom of a flask because the sample will be too thick for efficient water removal.

VALIDATION KNOWLEDGE BASE

If you have one that is excellent. Clamps, Gaskets and port caps are also available. The difference in particulates can greatly affect product freezing and ice crystal size. As mentioned earlier, each frozen product has a unique critical temperature. The tray is loaded with vials, placed on lyophilzer shelf in the freeze dryer and then the bottom part of the tray is slid out.

Thermocouple based unit Option to use your own thermocouples, or purchase thermocouples ready to go from Ellab. Some biological products can not tolerate large ice crystals and they must be freeze dried with smaller ice crystal sizes.

Freeze dryers can be informally classified by the type of product chamber: The vacuum system consists of a separate vacuum pump connected to an airtight condenser and attached product qualificwtion.

SP’s products support research and production across divers end user markets including pharmaceutical, scientific research, industrial, aeronautic, semiconductor and healthcare.

This valve can be closed for a short period of time and the subsequent rise in pressure in the product chamber can be measured. When the Pirani pressure reading decreases and approaches the lyophilier pressure reading of the capacitance manometer, little or no water vapor is present and it can be concluded that primary drying is complete.

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Product is either pre-loaded into vials which are then transferred to the shelf or it is loaded in bulk form directly onto a product tray. Headquartered in Warminster, Pennsylvania, SP Industries has production facilities in the Qualificattion and Europe and offers a world-wide sales and service network with full product support including training and technical assistance.

Regional sales associates, Distributors and service technicians are located throughout the world. It is OK if the thermocouple touches the bottom of the container. Secondary drying rates are dependant on the product temperature.

The clean steam piping must be L stainless steel. If drying in vials, it is good practice to insert the thermocouple in a vial located in the middle of the shelf.

Three successful, consecutive, runs are performed. DRY — Heat energy is then added to the product causing the ice to sublime. Laboratory pilot-sized shelf freeze dryers are often used to develop a cycle to be used for process scale-up to a larger production sized unit. Find a Product Specialist Request a Quote.

Slower shelf cooling rates do not necessarily yield larger ice crystals because of the effects of super-cooling.

Basic Principles of Freeze Drying

Larger ice crystals improve the speed of the freeze drying process because of the larger qualifictaion pathways left behind in the dried portion of the product as the ice crystals are sublimated. The refrigeration system can also be employed to cool shelves in the product chamber for the freezing of the product.

Silicone levels on swabs in the chamber should not exceed the negative control. The Vacuum System is tested by determining the blank-off pressure, pump ultimate pressure and leak-up rate.