Syringes

Blister

AMI 1000
Innovative CCIT solution for thepharmaceutical industry based on
Optical Emission Spectroscopy

Vials

AMI 1000
Innovative CCIT solution for thepharmaceutical industry based on
Optical Emission Spectroscopy

Improves sensitivity,
capacity and reliability ofyour integrity test

Your added value

Large detection range

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 microbiologicalingress 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 therisk of biological ingress of parenteral drugs, integrity tests
with a high sensitivity are required. Most test methods arevery challenging in regards to time effort, complexity or thelimitation of sensitivity and detection range.
An innovative solution
Our patented O.E.S. (Optical Emission Spectroscopy) method
does not require any specific tracer gas. Instead, the gas
mixture present in the container headspace of the primary
packaging is used to perform high sensitivity tests with highthroughput. A multi-gas sensor is used to independently trackthe different gases (i.e. argon, nitrogen, CO2, humidity,…)l3Improves manufacturing
productivity

Data storage
and traceability

Non-destructive anddeterministic test methods

Fast returnon investment

escaping from a leaky container exposed to vacuum. Our
method is non-destructive, deterministic, easy to use and to
set up, and has higher sensitivity than other conventional
methods. Furthermore, as sensitivity of the O.E.S. technology
doesn‘t depend on the free volume inside the test chamber,several samples can be tested simultaneously.
Ease of use
The products can be sampled directly from the production line
and loaded in the test chamber without any specific conditioning. At the end of the test sequence, the result is clearly displayed and a PDF report is automatically generated at thebatch closure. Full automation of the test cycle including loading/unloading of the samples can be easily implemented forin-line tests.
Dedicated to the pharmaceutical industry
AMI 1000 equipments have been qualified by leading pharmaceutical companies as in-process control (IPC) leak testing forblister packs. Our software is CFR21 part 111) compliant.

1)

Code of Federal Regulations by the United States Food and Drug Administration (FDA)

AMI 1000
Innovative CCIT solution for thepharmaceutical industry based on
Optical Emission Spectroscopy
Large detection range
Different detection methods can be combined in order to cover the complete detection range. Massive leak and fine leaktests are performed within a single test sequence, any additional gross leak test (e.g. blue dye ingress) can be omitted.
Deterministic test method
As no operator intervention is required, the measurement
results are totally objective. High accuracy measurements
can be achieved thanks to a calibration-validation sequenceof the equipment based on certified calibrated leaks.
High sensitivity, high throughput
High sensitivity tests
combined with highthroughput enables
trend analysis to early
indicate production issues. In high sensitivity
mode, O.E.S is able todetect 0.2 μm defectsize on glass containerswhich corresponds
to the sterility barrier
defined as the MALL
(Maximum Allowable
Leakage Limit) in theUSP3) <1207>
guidelines.

2)

United States Pharmacopia
The laptop is not provided
by Pfeiffer Vacuum
3)

Operation3)

l5
Versatile and high performance technology for various applications
Specific test chambers are designed according product format.

Samples

Blisters

Syringes & Vials

IV bags
Plastic bottles3)

Sensitivity
Orifice diameter3)
Air/N2 Leakage

Testduration

Air/N2 leak

Waterleak

0.4 µm2 · 10-5 mbar l/s

n.a.

0.4 µm2 · 10-5 mbar l/s
0.2 µm6 · 10-6 mbar l/s
0.4 µm2 · 10-5 mbar l/s
0.5 µm4 · 10-5 mbar l/s

Sharp edge orifice as defined in USP <1207> guidelines> 20-30 sec> 15 sec

2 µm~45 sec.
(high sensitivity mode)Advantages

Highest sensitivity test method available on the market
Outgazing of the drug itself can be used for gross leakdetection Applicable to peeling blisters
Air and water detected simultaneously
Test per batch to increase the troughput
MALL level can be achieved in high sensitivity mode

3 µm

> 20 sec

Air and water detected simultaneously

n.a.

> 20 sec

Test per batch (up to 50 or 100) to increase
the troughput

AMI 1000
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)

1

1·100

1·10 - 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 - 10

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

CHOCKED FLOWLAMINAR FLOW

1·10 - 110.1

1.0

10.0

Defect size (µm)

100.0

1 000.0l7
Dimensions
1409
460

1050

1075

485

575

Dimensions in mm
Technical data
AMI 1000
Power supply
Typical power consumption
Sensitivity
CDA supply
Quality
Pressure (min./max.)
Typical consumption
Calibration gas supply (CDA, N2, Ar, ….)
Pressure (min./max.)
Venting gas (Ambient, CDA, Ar, ….)
Pressure (min./max.)
User interface

SoftwareOperating system
Network connection
Interfaces (printer, bar code reader, data export)

90-250 V AC / 50-60 Hz
1,200 W
Down to 0.4 μm
2·10-5 mbar·l/s
Required for operation(1.3.1 according to ISO 8573-1)
6.3/10 bar rel. – 91/145 psig
2 Nl/cycle
Optional
6.3/10 bar rel. – 91/145 psig
Optional
0/1.5 bar rel. – 0/22 psig
10" Multi-touch Full HD color screen
Possibility to use a customer laptop via
Ethernet or WiFi connections.
21 CFR part 11 compliance
PDF GMP test and calibration reports
authentication local or domain (LDAP)
Remote access to data (optional)
Windows 10
1 x LAN (RJ45) WiFi AP2 x USB 3.0 (ext.)
1 x HDMI

Operating conditions
Temperature (min./max.)
Humidity (min./max.)Dimensions (l x w x h) (Including trolley)
Weight, (Including trolley)
Noise level

20 – 25 °C
30 – 65 %1,409 x 575 x 1,075 mm
55.5 x 22.6 x 42.3 inch
130 kg/287 lbs.
< 53 dB(A)Order information
Please contact your local Pfeiffer Vacuum sales adminstration

AMI 1000

CFR 21 part 11
compliant Software

Down to 0.4 μm
2·10-5 mbar·l/s
Sensitivity

Errors excepted. All data subject to change without prior notice. PL 0024 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