«LYOPHILIZER»に関連する英語の本
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lyophilizerに関する本と英語文献で使われた文脈を提供するための簡単な抜粋文。
1
Aseptic Pharmaceutical Manufacturing II: Applications for ...
is filled, it is pushed onto the lyophilizer shelf to fill half of it. During that operation
arriving vials are fed into the other transport frame. As each lyophilizer shelf is
filled, it is lifted up from the loader level and a new shelf is positioned for filling.
Michael J. Groves, Ram Murty, 1995
2
Validation of Pharmaceutical Processes, Third Edition
Part of the EQ that comes beforeany actual performance testing is the review and
verification of the lyophilizer design.Thisissometimescompletedasa separate task
and is often referred to as aDQ. This step, whether as aseparate DQ or as part ...
James P. Agalloco, Frederick J. Carleton, 2007
3
Lyophilization of Biopharmaceuticals
The major components of the lyophilizer that should be included are listed within
Table 2 and may also include sterilization and cleaning equipment, secondary
vacuum pumps, and other ancillary support equipment. Since the performance of
...
Henry R. Costantino, Michael J. Pikal, 2004
4
Validation Standard Operating Procedures: A Step by Step ...
... Protocol............................ 590 1500.90 Equipment Sterilization Performance
Qualification Protocol ... 594 1500.100 Lyophilizer Performance Qualification
Protocol........................ 598 1500.110 Lyophilizer Requalification Protocol.
5
Formulation and Process Development Strategies for ...
Lyophilizer manufacturers generally specify the maximum ramping rates for the
empty chamber. However, the performance with product load tends to be
significantly slower and should be determined during qualification of the machine
(Table ...
Feroz Jameel, Susan Hershenson, 2010
6
Pharmaceutical process validation
Between these steps, the vials are placed in freeze drying trays, offloaded from
the filling line, and then placed in the lyophilizer to be dried. In addition to media
fills for the filling operation itself, the aseptic transfer of the sterile product must be
...
Ira R. Berry, Robert A. Nash, 1993
7
The Mirage Man: Bruce Ivins, the Anthrax Attacks, and ...
They irradiated the spores, rendering them harmless to humans. Ezzell then
dried the material, using a standard lab machine called a lyophilizer. The result
was highly purified anthrax powder——-snow white, fine and fluffy. Ezzell and his
staff ...
8
Basic Plant Pathology Methods
To register the level of the vacuum, a vacuum meter must be provided. The
construction of a homemade lyophilizer is described.154~155 The basic steps of
lyophilization are (1) prefreezing of a cell suspension, (2) vacuum drying in a
frozen ...
James B. Sinclair, Onkar Dev Dhingra, 1995
Ablation The high velocities of vapor water migrating from containers during
sublimation can result in the loss of contents from the vial (19,20), resulting in
contamination of the lyophilizer interior, condenser, and vacuum pump, and
ultimately ...
Andrew Robinson, Michael J. Hudson, Martin P. Cranage, 2003
The stoppered vials are either transferred to a À80 freezer or frozen directly in the
lyophilizer (The VirTis Company, Gardiner, NY, Advantage Model with computer
control and a lyophilization chamber). Freezing time should be approximately ...
用語«LYOPHILIZER»を含むニュース項目
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Lyophilization Services of New England Completes Successful FDA …
... PAI at the Commerce Drive facility, the first inspection was for a bulk drug intermediate lyophilized in LSNE's 260 square foot lyophilizer. «PR Newswire, 6月 15»
GEA Highlights Freeze Drying Expertise at ACHEMA 2015
ALUS™ minimises the risk of operator/product contamination during lyophilizer loading and unloading, offering shorter processing times, ... «Benzinga, 5月 15»
Hospira (HSP) Receives FDA Warning Letter for Liscate Facility
Specifically, you mention that some vials may have slightly elevated stoppers as a result of them sticking to the lyophilizer shelf during the ... «StreetInsider.com, 4月 15»
Enteris plans to beat established API CMOs on lead times
... suite, multiple chromatography columns up to 1m diameter, an explosion-proof area for safe solvent handling and a bulk tray lyophilizer. «OutSourcing-Pharma.com, 2月 15»
Enteris BioPharma Launches Contract Manufacturing within 32000 …
... a Rainee homogenizer, a complete downstream purification suite, multiple chromatography columns, a bulk tray lyophilizer and an explosion ... «FiercePharma Manufacturing, 2月 15»
Research and Markets: Global Lyophilization Market Outlook 2019 …
The process in conducted in lyophilization equipment, which is commonly term as freeze dryer or lyophilizer. This process is frequently used in ... «Business Wire, 10月 14»
Concentrate on Your Concentration Process
Buying a lyophilizer/concentrator requires knowing your sample, sample size and the desired outcome. By considering your sample and the ... «Laboratory Equipment, 8月 14»
AmbioPharm to invest $5 million, create 20 jobs
The investment includes a 400-liter lyophilizer, three additional purification suites, additions to the quality control lab and warehouse space. «The Star, 6月 14»
AmbioPharm Inc. to expand North Augusta workforce, operations
Once sent to the local site, the material is dissolved into a liquid, placed into a lyophilizer, or large freeze dryer, and converted into a powder. «The Augusta Chronicle, 6月 14»
Kemwell Adds Lyophilization Capability
The lyophilizer has a shelf area of 7.5 sq.m. (~80 sq.ft) and is equipped with CIP and SIP facility. The maximum batch size ranges from 4,000 ... «PR Newswire India, 3月 14»
