APSS-2000 Automated Parenteral Sampling System0 pages

APSS-2000

Automated Parenteral Sampling System
BENEFITS
Defect Reduction

•t100% sample volume for greater accuracy
•tA precise sample volume within 0.1 ml
is achieved with the syringe sampler,
producing repeatable results
•tSamplerSight-Pharma software comes
with a Validation Information Notebook,
providing comprehensive software
development documentation and full IQ,
OQ, and PQ protocols
•tSamplerSight-Pharma complies with FDA
21 CFR 11

User-Friendly

•tReduce operator error and ensure process
accuracy with recipes for repeat sample
processing to USP, EP, or JP standards
•tAutomated particle counter calibration
wizard for full calibration or routine
verification
•tAlarm levels for pass/fail criteria ensure
quality control

Comprehensive System

The APSS-2000 syringe sampling system sizes and counts
suspended particulate matter in a wide range of liquids and
meets or exceeds all current USP, EP, and JP requirements.
Recipe functions allow the APSS 2000 to adapt to future
regulatory changes.
The APSS-2000 system consists of an SLS-1000 syringe
sampler, a LiQuilaz® E Series light obscuration spectrometer,
and SamplerSight-Pharma software, allowing reports to
meet 21 CFR 11 “Electronic Records and Signatures” rulings.

•tEasy-to-use, pull-down menus
•tSecurity password maintains system integrity
•tParticle measurements are reported per ml
or per container values
•tSmall sample volume minimizes waste of
expensive product
•tVarious custom report formats are available

FEATURES

•tSizing capability from 1.5 to 125 µm
•tFifteen user-selectable sizing channels
•tMeets and exceeds all USP, EP and JP
requirements
•tSample volumes from 0.2 ml to 1 liter
•tAdaptors for SVI and IV bag testing
•tAutomated sensor calibration

APPLICATIONS

•tPharmaceutical parenteral monitoring to
USP, EP, JP and FDA standards
•tParts/medical device cleanliness testing
•tLaboratory water sampling
•tWFI and Purified Water testing
•tFilter efficiency testing

Without measurement there is no control.