Syringes

Blister

ASM 2000
High performance CCIT solution for thepharmaceutical industry
based on helium mass spectrometry

Vials

ASM 2000
High performance CCIT solution for thepharmaceutical industry
based on helium mass spectrometry

High sensitive measurementsfor project and validation
studies of new containersYour added value

Turnkey solution

Our know-how
Pfeiffer Vacuum is one of the world´s leading providers ofvacuum and testing solutions. The product portfolio comprises vacuum pumps, measurement and analysis devices, components, as well as vacuum chambers and high performancedetection systems. Furthermore, we offer a unique portfolio ofequipments based on three technologies that are dedicated tothe pharmaceutical and medical markets. Leak testing andCCIT can be performed on a large variety of drug/container
combinations.
Integrity challenges
Contamination such as humidity, oxygen or microbiological ingress can impact drug stability throughout the product life cycle. To prevent the risks of stability failure of highly
moisture-sensitive drugs (e.g. dry powder for inhalation), or
the risk of biological ingress of parenteral drugs, integrity
tests with a high sensitivity are required. Most test methods
are very challenging in regards to time effort, complexity or
the limitation of sensitivity and detection range.
A proven solution
Helium mass spectrometry based upon ASTM F 2391-051) isapplicable to non-porous packaging such as vials, syringesand cartridges. Currently, the helium leak test, a deterministic
method, is being established as the gold standard for its sensitivity and versatility. Furthermore, helium leak detection offers the capability to also locate the position of a leak.

l3

User-friendlyinterface

Fast and fully automatic
test sequence to guarantee
high repeatability tests

Data storage
and traceability

Identifying the sourceof leaks using the“sniffer mode”

Key features
ASM 2000 is a comprehensive solution completely adapted
to the needs of pharma industry. ASM 2000 is the perfect solution for the validation and qualification of new containers.
Based on a high performance helium mass spectrometer leakdetector, it also includes a helium charging module, and canbe equipped with custom fixtures for the particular container
formats. The instrument is calibrated against NIST2)-traceable
standard leaks.
Dependable, fast and sensitive
Further advantages of the ASM 2000 are its high helium
pumping, its integrated automatic helium charging module aswell as the optimized free internal volumes. Those features
guarantee high performance measurements on helium filled
sealed containers and open sub-assemblies.The ASM 2000
sustains very high throughput, ensures the accuracy and thereproducibility of the measurement results, and allows ultra
fast cycle time.
Advanced software
The software proposes intuitive menus easy to navigate. Userlog in is required to operate the equipment and four accesslevels are available (operator, advanced user, maintenance,administrator). Test recipes can be managed for each part format. At the end of the test sequence, the result is clearly displayed and PDF test and calibration reports are automaticallygenerated at the batch closure.
1)
2)

American Standard for Testing and Materials
US National Institute of Standards and Technology

ASM 2000
High performance CCIT solution for thepharmaceutical industry
based on helium mass spectrometry

1)

1)

OperationThe laptop is not provided by Pfeiffer Vacuuml5High performance helium leak testing for validation and qualification of new packagings.

Specific tooling’s according container design
Automatic test sequence including He charging
Massive leak detection prior to He charging
Test duration < 20 sec.

■
■
■
■

1·10-4900

700

Pressure (mbar)

P2(air/helium)

1·10-6600
1·10-7500
400

1·10-8300
200

P1(vacuum)

1·10-9100

QHe

1·10-1000

12
3
4
P2 (air/helium)
P1 (Inlet ASM)
QHe

5678910111213141516Time (ms)Test of open containers

Sniffer probe forleak localization

Helium spray gunfor charging vials

Test of He pre-filled containers■■■

Vacuum test chamber according container design
Test chamber volume: 3 liters max.
Typical test duration < 8 sec. (depend on free volume)

Helium Leakage (mbar·l/s)

1·10-5800

ASM 2000
Equivalence between
defect size & air leak rate
Leak rate versus defect size
Historically, dye ingress testing has been the container closure
integrity test of choice. The detection limit of this method isaround 20 μm. Since the test is strictly visual, the detection limit has experimentally been determined by using orifices ofknown diameter. As a consequence, tightness criteria in pharmaceutical industry are usually expressed as an equivalenthole diameter in μm. However, an equivalent hole diameter is
not enough to define the tightness criterion of a packaging.
Depending on the diameter of the hole, the leak path (length)
must be considered in order to define a leak rate (atm · cc/s)
which corresponds to a tightness criterion.
■■■

For large diameters (typically > 100 μm), the leak can begenerally considered as orifice (leak path of negligiblelength) as defined in USP <1207.1> section 3.9. This corresponds to the “CHOCKED FLOW” regime and the leak rateis directly proportional to the surface of the orifice (greencurve). For smaller diameters, the leak path (wall thickness)
also needs to be considered. Therefore, the leak rate is nota function of the square of the equivalent hole diameter
anymore. Moreover, different flow regimes must be considered for calculation of the leak rate.
In “LAMINAR FLOW”, the viscosity of the gas (dependingon the gas temperature) is the parameter which determines
gas-to-gas variations of media transfer through the leak.
In the region of smallest diameters there is another flowtransition. In “MOLECULAR FLOW” regime the molecularmass of the gas and its temperature are the driving parameters. As shown on the attached graph, the difference
between the USP <1207> orifice calculation and the realgeometry of the leak is very important for holes with verysmall diameters.

General introduction (Leakrate / Hole diameter)
General introduction (Leakrate / defect size)
QAir (mbar·l/s) = f [Hole diameter (µm)]
1·103Boundary conditions:
Air leak rate
1 atm. differential pressure
Leak path (wall thickness) = 250 µm
Headspace volume = infinite

1·102
1·10

Leak rate (mbar·l/s)

11·1001·10 - 1
1·10 - 2
1·10 - 3US

1·10 - 4

P<7120.1>

Q_Orifice

Q_Laminar

1·10 - 5
1·10 - 6

Q_Molecular

1·10 - 7
1·10 - 8
1·10 - 9

MOLECULAR FLOW

1·10 - 10QAir (mbar · l/s) =f [defect size (µm)]

CHOCKED FLOWLAMINAR FLOW

1·10 - 110.1

1.010.0

Defect size (µm)

100.0

1 000.0l7Dimensions
7 screenpositions
125°

2001052

15011941085

485

221409460
5751409

Dimensions in mm485

Technical data
ASM 2000

SoftwareOperating system
Network connection
Interfaces (printer, bar code reader, data export)
Operating conditions
Temperature (min./max.)
Humidity (min./max.)Dimensions (l x w x h) (Including trolley)
Weight, (Including trolley)
Noise level

Vacuum and sniffing leak detection
460

Test methods
Measurement range (vacuum test)
Quantitative range – Fine leak Helium
Qualitative range – Gross leak Helium
Qualitative range – Massive leak Air
Minimum detectable He leakage (sniffing test)
Power supply
Typical power consumption
CDA supply
Quality
Pressure (min./max.)
Helium supply
Pressure (min./max.)
Nitrogen supply
Pressure (min./max.)
User interface< 10-9 – 10-5 mbar l/s
10-5 – 10-3 mbar l/s> 10-3 mbar l/s> 10-5 mbar l/s
90-250 V AC / 50 – 60 Hz
3,750 W
Required for operation(1.3.1 according to ISO 8573-1)
4.5/10 bar rel. – 65/145 psig
Required for operation
4.5/10 bar rel. – 65/145 psig
Required for operation
4.5/10 bar rel. – 65/145 psig
10“ Multi-touch Full HD color screen
21 CFR part 11 compliance
PDF GMP test and calibration reports
authentication local or domain (LDAP)
Windows 10
1 x LAN (RJ45)
2 x USB 3.0 (ext.), 1 x HDMI
15 – 25 °C
30 – 80 %1,409 x 575 x 1,194 mm
55.5 x 22.6 x 47 inch
140 kg/308 lbs.
< 53 dB(A)Order information
Please contact your local Pfeiffer Vacuum sales adminstration

ASM 2000<10-9 – 10-5 mbar l/s
Quantitative range –Fine leak Helium

CFR 21 part 11Compliant softwareErrors excepted. All data subject to change without prior notice. PL 0025 PEN (March 2022/PoD)Are you looking for an
optimal vacuum solution?
Please contact us:
Pfeiffer Vacuum GmbHGermany
Phone +49 6441 802-0

www.pfeiffer-vacuum.com