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Freeze Dryer Lyophilizer

Perform general operational controls verification testing. [Pg.141]

Operate system throughout the range of operating design specifications or range of intended use. [Pg.141]

Perform vacuum pump evacuation rate test to verify that the vacuum pump evacuates the chamber at the rate specified. [Pg.141]

Perform chamber vacuum and positive pressure integrity verification studies to verify that the chamber does not leak. [Pg.142]

Perform controller security challenges to verify that lyophilization cycle parameters cannot be altered without appropriate supervisory control. [Pg.142]


A freeze dryer (lyophilizer) was employed for vacuum drying (23°C at -0.05... [Pg.162]

Vials/ampoules washing machine Vials/ampoules/syringes filling Freeze dryer (lyophilizer)... [Pg.201]

The sterile solutions are filled in different sizes of vials and lyophilized in freeze dryer under aseptic conditions. For this purpose, all operations and conditions were validated according to the approved protocols. To ensure sterility during aseptic processing, the frequency was established to revalidate all sterilization cycles by one-heat penetration/distribution study and microbial challenge test using B. stearothermophilus strip. [Pg.610]

Place the frozen eluates in a freeze dryer for about 20 h. Carefully rinse the wall of the tubes three times with 500 pi distilled water and transfer the dissolved NeuAc to small 2-ml reaction vials with pierced caps. Freeze in liquid nitrogen and lyophilize again for about 13 h. Store residues at -20°C until determination of NeuAc. [Pg.345]

For solid dssue such as that obtained from tumors, rapidly grind to a powder while frozen (liquidnitrogen or-70°C), then lyophilize on a freeze-dryer. Redissolve the residue in extracdon buffer (sssNotes 1 and 2). [Pg.276]

K. Nakahira Validation of deep vacuum vapor phase hydrogen peroxide sterilizer retrofit to a production lyophilizer. PDA Asian Symposium, Tokyo, 1994, pp. 16-616. M. Steiner, VHP—Sterilization of freeze-dryers. ISPE Seminar Lyophilisation (Antwerpen, Nov. 1994), International Society of Pharmaceutical Engineering (ISPE). [Pg.336]

The functional relationship between product temperature, on the one hand, and shelf temperature and chamber pressure, on the other hand, is affected by many factors including the size and design of the lyophilizer, the characteristics of the product, and the time evolved since the start of primary drying. With a sucrose formulation in vials, we have observed a maximum primary drying product temperature rise of -i-5°C when the shelf temperature was varied from -15 to -i-30°C, whereas a pressure variation from 30 to 250 microbars generated an increase of around -i-2.5°C. With a lactose formulation in ampoules lyophilized in a larger freeze-dryer equipped with a plate-type condenser, the effect of pressure was found to be predominant -i-6.5°C for a pressure move from 50 to 300 microbars, versus -t-l°C for a shelf temperature move from 0° to 25°C. [Pg.382]

Annealing below T did not result in increased drying rates. Based upon that finding the authors proposed a new aimealing-lyophilization method of T determination which can be carried out with only a balance and a freeze-dryer, measures T over any time scale desired, and has the additional advantage that a large number of candidate formulations can be evaluated simultaneously [4]. [Pg.142]

The lyophilization of samples in vials on the shelf of a freeze-dryer presents a unique challenge in that the perimeter vials receive additional... [Pg.156]

A lyophilization process usually includes three steps. First, the aqueous solution, that has been filled into containers (such as vials and trays), is frozen to lower than —40°C. Next, in the primary drying, the freeze-dryer chamber is evacuated and the shelf temperature is elevated to sublimate bulk water (also termed free water) out of the system. Finally, the shelf temperature is further increased to remove bound water by desorption. [Pg.234]

An integral HTF system allows complete specialization of these two loops giving maximum flexibility and dependability to the process. The integral HTF system technology applied to industrial freeze-dryers presents advantages process-wise for both freezing and lyophilization control and validation. [Pg.529]

Ice capacity verification that the condenser was able to hold an ice capacity representing a worst-case condenser load. The test is performed with the shortest lyophilization recipe that can be used to load the freeze-dryer with the vial format giving the worst-case load (maximum water to sublime). [Pg.539]


See other pages where Freeze Dryer Lyophilizer is mentioned: [Pg.19]    [Pg.141]    [Pg.19]    [Pg.141]    [Pg.314]    [Pg.65]    [Pg.498]    [Pg.340]    [Pg.362]    [Pg.323]    [Pg.70]    [Pg.216]    [Pg.128]    [Pg.381]    [Pg.387]    [Pg.397]    [Pg.402]    [Pg.403]    [Pg.130]    [Pg.1443]    [Pg.1807]    [Pg.2661]    [Pg.1695]    [Pg.665]    [Pg.261]    [Pg.265]    [Pg.253]    [Pg.14]    [Pg.144]    [Pg.270]    [Pg.309]    [Pg.559]    [Pg.565]    [Pg.566]    [Pg.576]    [Pg.580]   


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Dryers

Freeze-dryers

Lyophilic

Lyophilization freezing

Lyophilized

Lyophilizer

Lyophilizers

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