Rev 012, 04/11
9
© SP Scientific 2011
Chapter
3
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
Note: It is necessary to acquaint yourself with the use of the LyoManager II software prior to
performing these runs.
Once the system is fully installed and operational, a leak rate and system test should
be performed (see page 12-13 for instructions on how to perform). The baseline
performance data should be kept with this instruction manual. These same tests may
be performed at operator-determined intervals during the life of the system. This will
help determine if the freeze dryer is still working to full specifications. If full
specifications are not met after the system has been used for a period of time,
maintenance procedures should be followed. If this still results in poor test
performance SP Scientific Service should be contacted.
These baseline specification runs should be performed before any product is
processed in the freeze dryer. The Leak Rate Test measures the vacuum integrity of
the system. During the Leak Rate Test, the condenser and vacuum pump are
activated. When the system reaches the operator selected vacuum setpoint, the
vacuum pump automatically shuts off and the rate of pressure rise is measured for a
set period of time. The LyoStar should have a rate of rise no greater than 30 mT/hour
in a dry and empty chamber. The Leak Rate Test takes approximately 1 hour to run
(using the factory suggested parameters).
Summary of Contents for LYOSTAR II
Page 1: ...LYOPHILIZER OPERATOR S MANUAL FTS SYSTEMS LYOSTAR II STANDARD...
Page 2: ......
Page 6: ...iv Rev 012 04 11 SP Scientific 2011...
Page 29: ...FTS Systems LyoStar II Operating Your Lyophilizer Rev 012 04 11 21 SP Scientific 2011...
Page 38: ...Data Management FTS Systems LyoStar II 30 Rev 012 04 11 SP Scientific 2011...
Page 52: ...Optional Isolation Valve FTS Systems LyoStar II 44 Rev 012 04 11 SP Scientific 2011...
Page 58: ...Optional Cleanroom Configuration FTS Systems LyoStar II 50 Rev 012 04 11 SP Scientific 2011...
Page 66: ...General Maintenance FTS Systems LyoStar II 58 Rev 012 04 11 SP Scientific 2011...
Page 70: ...Appendix A Troubleshooting FTS Systems LyoStar II 62 Rev 012 04 11 SP Scientific 2011...
Page 71: ......
