FTS Systems LyoStar™ 3
Operating your Lyophilizer
Rev 006, 01/14
19
© SP Scientific 2014
Drying Step 17
Some products may require an additional drying step even when they appear dry. It is
during this phase that any remaining unfrozen water is removed from the product.
Using the lyophilizer’s control system, the temperature is typically increased during
this step to remove bound water until the residual water content falls to the range
required for optimum product stability. The shelf temperature setpoint should be set
higher than the temperature setpoint used in step 16 of drying for several hours in
order to remove residual water. Some products may also benefit from an increased
pressure setting during this step. The pressure setpoint may be modified as needed
during this phase based on product characteristics.
Completing the Cycle
When the cycle completes, both the vacuum and condenser systems must be shut
down.
If your system is equipped with stoppering and you are processing product in vials,
activate the stoppering mechanism to seal your product vials. Stoppering may be
executed at any desired pressure, using air or an inert gas for backfill, or while the
system is under vacuum. Stoppering must be performed with evenly distributed vials
of equal height to ensure uniform stoppering force and to prevent vial shifting.
Note: For additional information, refer to Chapter 7: Stoppering.
Release, or break, vacuum from the system prior to unloading your product. Do not
attempt to open the product or condenser chamber doors until the system pressure
returns to ambient pressure.
Unplug product probes and remove your product from the product chamber.
Defrost
The condenser should be defrosted after each freeze-drying cycle. LyoStar™ 3
lyophilizers utilize hot gas from the compressor to warm the condenser coils during
the defrost process.
CAUTION! DO NOT CHIP AWAY AT ICE WITHIN THE CONDENSER AS DAMAGE
TO THE CONDENSER MAY RESULT.
After removing the ice and melted condensate from the condenser chamber,
thoroughly clean and rinse the condenser with a mild detergent or baking soda
solution to neutralize any acids that may be present.
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...
Page 81: ......
