1. KHS Series – Headspace Leak Detection | 3
KHS Series – Headspace Leak Detection
Vials, Syringes, Ampoules and Cartridges
Inspection Technology
2. 2 | KHS Series – Headspace Leak Detection
KHS Series automated
Headspace leak detection
The KHS series Automated Inspection Machine
is engineered for safe operation, ease-of-use
and compliance with cGMP standards. The
machine integrates the proven Headspace
modules of Lighthouse Instruments into a
robust Bosch mechanical platform. The result
is a comprehensive leak detection machine
that handles a wide range of applications
with the highest accuracy and efficiency.
Inspect ampoules, vials, cartridges and
syringes for permanent and temporary
leaks at rates to 600 per minute
Bosch and Lighthouse cooperation:
Bosch Packaging & Lighthouse
Instruments join efforts to offer the
best-in-class headspace leak detection
machine. This cooperation is based on
the complementary strengths of both
partners:
▶ Bosch as a market leader in
machinery for pharmaceutical
inspection applications (Former
Eisai Machinery)
▶ Bosch Expertise in combining
inspection technologies with robust
and gentle mechanical platforms at
all speeds
▶ Lighthouse as the pioneer in laser
spectroscopy headspace analysis
with more than 15 years experience
and the largest installed base
worldwide
▶ Lighthouse patented best-in-class
Headspace Laser Spectroscopy
technology
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Headspace Laser Spectroscopy
Robust and sensitive technology to detect permanent and temporary leaks
Technology description:
Laser Headspace Analysis (HSA) is performed
using Frequency Modulation Spectroscopy (FMS)
by measuring oxygen absorption at 760 nm
and moisture absorption at 1,400 nm. It is a
non-destructive and rapid method which is
sensitive to all leak sizes.
Main applications:
Laser Headspace Analysis is the preferred
leak detection technology for:
▶ Lyophilized products
▶ Products filled under vacuum
▶ Products purged with inert gases
Calibration concept:
The calibration and measurement performance
are continiously monitored using Lighthouseʼs
patented calibration system.
Permanent standards built into the machine
allow automatic (re-) calibration and continuous
performance monitoring and background
correction.
The machine uses certified calibration standards:
▶ Oxygen and nitrogen levels
▶ Moisture levels
▶ Vacuum levels
Benefits of the Bosch/Lighthouse
measurement concept:
▶ Flexible measurement configuration:
– Single measurement of oxygen,
moisture or vacuum
– Combination of oxygen, moisture
and/or vacuum measurements
▶ Multi-head configuration with
a built-in measurement redundancy
to prevent down time even in
the event of a head failure
▶ Equivalent measurement performance
in plastic, molded and tubing glass,
clear and amber glass
4. KHS Series – Headspace Leak Detection | 4
KHS Series Automated Headspace Leak Detection
Robust and versatile platform for 100% CCI testing
The KHS Series has been developed based on a
proven and robust platform and according to the
highest Bosch quality standards. The Design
corresponds to the latest pharmaceutical norms and
guarantees optimal accessibility and maintenance.
Main mechanical and electrical features:
▶ Integrated control box for the highest
measurement accuracy and increased accessibility
▶ Re-designed module housing for higher robustness
and safety
▶ Automatic re-inspection
▶ Automatic height-adjustment of all measurement
modules to increase measurement accuracy and
reduce changeover time
▶ 21.5 widescreen touch-panel with enhanced
HMI software allows ease of operation
Additional advanced features:
▶ NIR application to measure the moisture level
in the lyophilized cake
▶ Integrated coding unit: on an extended layout
a coding and verification unit can be integrated
to print alpha-numeric and/or 2D matrix code.
The code is verified by camera and non-conforming
containers are ejected
▶ In-field retrofitting to integrate NIR application,
add laser modules or additional formats and
products
Benefits of the KHS Series:
▶ Compact platform for 100% CCI
combined with NIR measurement
and coding function
▶ High detection rate and low false
rejection resulting from automatic
re-calibration and automatic re-inspection
▶ Fixed measurement modules
to reduce wearing
▶ Ergonomic design for optimal
accessibility and maintenance
▶ Tool-less and quick changeover
▶ Easy and user-friendly operation,
setup and validation
5. 1,450
3,925
1,980
2,800
5 | KHS Series – Headspace Leak Detection
Technical data and specifications
General
Inspections and Features
Machine capacity (containers per hour) 36,000
Container types Vials, ampoules, cartridges and syringes
Max. body diameter (mm) 85
Max. container height (mm) 180
Machine weight (approx. in kg) 3,000
Power supply 3 phase, 400 VAC + N + PE, 50 Hz, 4 kVA
Air supply 490–590 kPa (free of moisture and oils)
Air consumption approx. 200 NL/min
Nitrogen supply 350–550 kPa, purity 99.995%, dew point -30 °C
Nitrogen consumption max. 10 NL/min/sensor – typ. 5 NL/min/sensor
Ambient temperature +15 °C / +25 °C (59°F / 77°F).
Relative humidity 0–75% RH and no condensation
Headspace technology Frequency Modulation Spectroscopy. Measurement of oxygen,
moisture and pressure levels
Measurement system Up to 4 Lighthouse laser headspace modules
Multi-head configuration to prevent down time
Calibration Permanent standards built into the machine allow automatic (re-)calibration,
continuous performance monitoring and background correction
NIR inspection Optional moisture measurement of the lyophilized cake
Coding Optional coding and verification of alpha-numeric and/or 2D matrix code
*Specifications are subject to change without notice.
