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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VALIDATION KNOWLEDGE BASE

Ellab Digital Pressure Sensor: Primary drying is a top-down process with a well-defined sublimation front moving through the product as it dries. Production freeze dryers are usually configured for operation in a clean room environment and can have the ability for clean-in-place CIP and steam sterilization SIP.

Several analytical methods are available for determining that primary drying is complete. User Portal Sign in Register. 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. Processing and formulation development are important steps often taken to make a product ready for freeze drying and usable for its specific application.

Loss of weight from a weighed amount of water in trays is not less than the stated capacity of the condenser. The refrigeration system must be able to maintain the temperature of the condenser substantially below the temperature of the product. It is OK if the thermocouple touches the bottom of the container.

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We’ll assume you’re ok with that, but you can opt-out if you wish. We offer these with Rigid and Bendable probes. Qualificcation drying is continued until the product has acceptable moisture content for long term storage. DRY — Heat energy is then added to the product causing the ice to sublime.

Freeze Drying / Lyophilization Information: Basic Principles

SP Scientific qualificcation and distributors look forward to helping you reach your goals. The cycle time can often be substantially reduced by investigating several factors:.

Compressed Air, Nitrogen, Vacuum, etc. Regional sales associates, Distributors and service technicians are located throughout the world.

When the product temperature equals the shelf temperature, it can be inferred that primary drying is complete. Also, the flask might break due to uneven stress.

Vacuum System The blank-off pressure, pump ultimate pressure and leak-up rate are for baseline purposes only. Freeze drying is the removal of ice or other frozen solvents from a material through the process of sublimation and the removal of bound water molecules through the process of desorption.

Purified Water System IQ. TrackSense Pro Data Loggers.

Basic Principles of Freeze Drying

Option to use your own thermocouples, or purchase thermocouples ready to go from Ellab. Three successful, consecutive, runs are performed. Using the vapor pressure of ice table is a scientific way to determine an appropriate pressure for freeze drying. Because the condenser is maintained at a lower energy level relative to the product ice, the vapors condense and turn back into solid form ice in the condenser.

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Choosing a freeze dryer depends on the product characteristics as well as many other application-based variables including the container that the product will be dried in, the shelf area or number of ports required to accommodate the quantity to be dried in each batch, the total volume of ice to be condensed and whether there are any organic solvents.

Headquartered in Warminster, Pennsylvania, SP Industries has production facilities in the USA and Europe and offers a world-wide sales and service network with full product support including training and technical assistance.

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. Frozen products can be categorized as either crystalline or amorphous glass in structure. The vacuum system consists of a separate vacuum pump connected to an airtight condenser and attached product chamber.

When working with products with low collapse temperatures, it may be necessary to wrap or insulate the flask to slow down the rate of heat transfer and avoid collapse. The purpose of the condenser is to attract the vapors being sublimed off of the product.

Although a few products are simple crystalline materials, the vast majority of products that are lyophilized are amorphous and form glassy states when frozen. SP Scientific is constantly striving for superior service and quality.

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