Laser Space Analyzer, LSA

JMC (Japan Machinery Company)

For Completely Non-Destructive and Rapid Container Closure Integrity Test

Oxygen concentration, pressure, moisture content inside the transparent container such as vials and ampoules can be completely Non-Destructive measured in just a few seconds. Conformity to container integrity test USP 40 NF 35 (USP 1207.2 2.2: Laser-Based Gas headspace Analysis).

Measurement Target

Container Integrity TestUSP39-NF34 1207.2 Compliant

Listed in USP 1207.2 2.2 as Laser Gas Headspace Analysis
Testing decompressed containers for lyophilized formulations
For2.2.2 APPLICATION Lines 14-18
- A test results not meeting specification could not be due to package leakage, or could result from improper package filling or assembly processes that caused the package headspace to be out of specification.

- A test result that meets specification may confirm package integrity if enough time has elapsed since product–package preparation for measurable leakage to have occurred, assuming that the initial preparation of the test sample met manufacturing standards.

×FAIL

- Change in pressure /oxygen concentration is measured with the lapse of time.

- There could be leakage from the container. Problems in the filling/assembly stages could be found.


✔PASS

- Change in pressure /oxygen concentration with the lapse of time is within the tolerance.

- No leakage from the container. There is no problem in the filling /assembly stages. By using a decompression chamber, products plugged under atmospheric pressure also can be measured.


Application

Nitrogen Substitution Rate Confirmation

- The measured oxygen concentration can be referred to for optimization of the nitrogen filling.
- Can check validated nitrogen substitution amount.

What can the inappropriate substitution rate tell us?

- Nitrogen gas substitution power can be insufficient.

- The rubber cap can be not properly plugged, etc.

Quality Assurance and Hot/Cold Spot Confirmation for Lyophilized Formulations

- Predicts the degree of dryness of a lyophilized formulation from the moisture content in the headspace.

- Mapping of moisture level of the lyophilized formulation chamber.

Advantages

Compliant with “Laser Gas Headspace Analysis Method” listed in USP <1207.2>

Highest Detection Limit

- φ 0.1um pinholes can be detected.

Shortest Measuring Time

- Several seconds per container (default measurement time: 5sec).

Completely Non-Destructive

- Enables multiple measurements and follow-up test on the same sample;
you do not need to waste your valuable samples anymore.

Compatible with Most Containers
Time-Saving Consecutive Test

- Height and width of the measuring unit are adjustable to the size of your containers.

- 10-sampleholder for each container type is produced and supplied.

- Measurement completes in typically several seconds per container.

- Consecutive measurement can prevent errors due to the multiple operators.


User-friendly Software

- Touch Panel Operation

Simple and user-friendly interface.

- “Clear Level”

Thresholds can be set for measuring vials with adhesive powder inside, or colored vials.

- Manual Measurement and AutomatedConsecutive Measurement Available

Enables efficient measurement.

- Calibration

Automatic and multipoint calibration available.

You can specify a value close to the measured value and improve accuracy.

- Measurement Data

Graphs, tables and report export available.

- Display Language

English and Japanese.
*Other languages can also be Supported.

- Automatic Centering Function

Always catch the output waveform accurately

- CFR 21Part 11 Compliant Version Available

Reliability

Typical measurement accuracy (actual values)

SD when measuring the φ30mm transparent vial with 20% oxygen inside.

- Approx. ±0.1 when measurement time/vial is 10 sec.

- Approx. ±0.15 when measurement time/vial is 5 sec.

*Measurement accuracy depends on the size, thickness accuracy, transparency, color, etc., of the container.

Specifications

Model

LS-07 Series

Wavelength: 763nm Measurement target: oxygen (%).

LS-14 Series

Wavelength: 763nm Measurement target: oxygen (%).

LS-21 Series

(2 Measurement Units Installed)

Wavelength: 763nm Measurement target: oxygen (%).

Wavelength: 1,382nm Measurement target: moisture (mg/L, Torr), pressure (Torr).


Hardware

Container size

φ12-30mm *Custom-made holders for smaller/bigger containers available.

Processing speed

From pressing the Start button until the holder returns: 97sec for10 vials.
*When measurement time per vial is 5sec.

Typical Processing Speed/Container: 9sec.

Measurement Time: 1–5sec.

Operation

Intermittent operation by constant-pitch feeding.

Automatic from carriage to measurement.

Workpiece Supply

Supply by dedicated holder.

Workpiece Feeding (drive)

Single-axis robot.

Measurement Unit

Two units can be installed.

The height and width are manually adjustable using the position indication dial.

Workpiece rotation mechanism

Rotated during measurement.


Utility

Power Supply

100 V, single phase.

Nitrogen Purge

Optional (purged only during measurement).

Compressed Air

Not Required.

Operation buttons

Operation, Emergency Stop, Nitrogen ON/OFF, Independent Measurement (without automated feeding).


Software

Display Language

English and Japanese

*Other languages can also be supported.

Calibration

Automatic and multipoint calibration available.

Calibration containers (standards) are supplied with the system on installation.

Calibration time: Approx.58 sec (for two-point calibration).


Other

Interface (Output)

Two USB ports.

Operation

Screen touch with voice guidance.

10-sample Holder

Specific holder is supplied for each container size.

Numbering on the holder to specify the container set position.

Device Startup Time

50 seconds (From power on until the screen is displayed).

Device Shutdown Time

26 seconds (Until the device completely shuts down).

Size

640 (W) x 575 (D) x 600 (H) mm.

Weight

35kg (body 34.3kg + one holder piece 0.7kg).

Extensibility

Scale-up: Laboratory, semi-automated and fully-automated models.

Simultaneous measurement by multiple measurement units available Laser.



Catalog

LSA Catalog, English

LSA Catalog, Korean




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