Rev 006, 01/14
15
© SP Scientific 2014
Chapter
4
Operating your Lyophilizer
PRACTICAL OPERATING TIP. YOUR LYOPHILIZER IS SUPPLIED WITH A SOPHISTICATED
CONTROL SYSTEM. REVIEW YOUR CONTROL SYSTEM OPERATOR’S MANUAL BEFORE
OPERATING YOUR FREEZE DRYER.
WHEN IN OPERATION, ALWAYS ASSUME THE LYOPHILIZER CHAMBERS ARE UNDER
VACUUM. ALL GLASSWARE UNDER VACUUM REPRESENTS A SIGNIFICANT IMPLOSION
HAZARD. INSPECT ALL GLASSWARE USED IN THE LYOPHILIZER FOR VISIBLE DEFECTS
(CRACKS, CHIPS, OR SCRATCHES) PRIOR TO USE. DO NOT USE GLASSWARE THAT IS
DEFECTIVE.
LIQUID NITROGEN IS A HAZARDOUS MATERIAL THAT BOILS AT -194 °C. LIQUID NITROGEN
PRESENTS A SEVERE FROSTBITE HAZARD. WHEN USING LIQUID NITROGEN, WEAR
PROPER EYE PROTECTION AND PROTECTIVE GLOVES.
WEAR APPROPRIATE EYE PROTECTION AT ALL TIMES WHEN WORKING WITH OR
ANYWHERE NEAR A LYOPHILIZER.
Leak Rate and Function Testing
Once LyoStar™ 3 is fully installed and operational, SP Scientific recommends
performing automatic leak rate and function tests using your control system software.
Refer to the lyophilizer’s performance specifications when determining whether or not
the results of these tests are successful. Consider successful test results baseline
performance data. Maintain copies of test results for reference during routine testing
of the lyophilizer.
Note: For additional information regarding the automated Leak Rate and Function Test, refer to
your control system operator’s manual.
Preparation and Pretreatment
Your LyoStar™ 3 lyophilizer is a high-performance R&D and pilot-scale tray freeze
dryer, allowing you to process product in many ways including in bulk trays or vials. If
you choose to process your product sample in a container, note that your container
volume should always be at least two to three times the volume of your sample (
i.e.
,
use 80 ml containers or larger when preparing 40 ml samples).
PRIOR TO OPERATING YOUR FREEZE DRYER, ENSURE THAT THE PRODUCT
CHAMBER, SHELVES AND CONDENSER ARE CLEAN AND DRY. ENSURE THAT THE
STOPPERING ASSEMBLY IS IN THE RETRACTED POSITION BEFORE PROCEEDING.
Summary of Contents for LYOSTAR 3
Page 2: ......
Page 6: ...iv Rev 006 01 14 SP Scientific 2014...
Page 10: ...Contents FTS Systems LyoStar 3 viii Rev 006 01 14 SP Scientific 2014...
Page 18: ...Getting Started FTS Systems LyoStar 3 8 Rev 006 01 14 SP Scientific 2014...
Page 30: ...Operating your Lyophilizer FTS Systems LyoStar 3 20 Rev 006 01 14 SP Scientific 2014...
Page 36: ...Liquid Nitrogen Trap FTS Systems LyoStar 3 26 Rev 006 01 14 SP Scientific 2014...
Page 48: ...Sample Extractor Assemblies FTS Systems LyoStar 3 38 Rev 006 01 14 SP Scientific 2014...
Page 52: ...Stoppering FTS Systems LyoStar 3 42 Rev 006 01 14 SP Scientific 2014...
Page 56: ...Shelf Latching FTS Systems LyoStar 3 46 Rev 006 01 14 SP Scientific 2014...
Page 74: ...Appendix A Sample Recipe FTS Systems LyoStar 3 64 Rev 006 01 14 SP Scientific 2014...
Page 80: ...Appendix C Stainless Steel Cleaners FTS Systems LyoStar 3 70 Rev 006 01 14 SP Scientific 2014...
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