Pharmaceutical Products

Stability Testing

Test Chambers for Stability Tests on Pharmaceutical Products

according to the ICH Q1A and FDA Guidelines

Quality

Environmental Simulation

nvirotronics is part of the Weiss

Environmental Technology Group.
We are one of the most important
producers of standard test devices and
special test systems for environmental
simulation worldwide.
Our range of products is comprised of
systems for simulating exposure to weather
as well as systems for temperature, humidity,
therrmal shock, vibration and corrosion tests.
These systems are available in virtually any
size for application in research, development,
quality assurance and production.
In order to safeguard consistently high
quality and the stability of medical and
pharmaceutical products, we offer you a
comprehensive standard range of stability test
chambers. Depending on your requirements,
our equipment range can extend to walk-in
test chambers and special systems of any
size. Envirotronics stability test chambers are
based on the GMP, FDA and ICH guidelines.
Our efficient after-sales service ensures
optimum support for our customers as well as
a high degree of system operation reliability.
Decades of experience in the varied fields
of application coupled with an intensive
exchange of ideas and experience with our
customers from all over the world ensure your
lasting partnership with Envirotronics.

Confidence

Ensure

Only Tested Pharmaceuticals

get the Required Approval

o meet the quality criteria of the stability

tests, the chemical, microbiological,
and physical characteristics of
pharmaceutical substances are tested after
exposure to temperature and humidity over a
defined period.
To that end, the following climate conditions
were established for long-term testing,
accelerated testing, and testing at intermediate
conditions according to the ICH* Guideline
Q1A.
Testing at intermediate conditions is carried
out in case there are deviations between the
first two forms of testing.
Long-term testing
at +25C / 60% RH or
+30C / 65% RH
Accelerated testing
at +40C / 75% RH
Intermediate testing
at +30C / 65% RH
The following test conditions were stipulated
for substances or pharmaceuticals in semipermeable packaging:
Long-term testing
at +25C / 40% RH
Accelerated testing
at +40C / <25% RH
During the entire test, the deviation in
temperature is stipulated at 2C and the
deviation in relative humidity is stipulated at
5% RH
In the ICH* Guideline Q1B, the methods
for performing photostability tests are
established with an irradiation dose of 1.2
million lxh and an integrated UV part of 200
Wh/m2.

Climate Test Chambers with Optimized Storage Areas

for Reliable Stability Testing of Pharmaceuticals

ccording to the ICH* Guideline Q1A,

stability tests have to be performed
under defined climatic conditions in
order to provide evidence of the stability of
active substances and pharmaceuticals.
In cooperation with the pharmaceutical
industry, we have developed a specific range
of test cabinets and test chambers to meet
these requirements.
Stability tests are an important step
in the development of new drugs and
pharmaceutical substances and an
indispensable element in the licensing
process defined by federal regulating
authorities. However, these tests are just
as important for safeguarding the quality of
the product within the framework of quality
assurance.

Together with committees from the

pharmaceutical industry, experts from the
licensing authorities (such as the FDA)
have developed the ICH* Guidelines for
the harmonization of stability tests. These
guidelines define standardized storage and
batch evaluation as well as the time sequence
of the required analytic tests.
The ICH* Guidelines are valid in the EU,
Japan and the USA. For other regions,
climate zones have also been established.
However, depending on the respective
country, the execution of such tests may not
be mandatory.
* International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for
Human Use.

Detail

Attention to Every

Product Diversity

ur comprehensive standard line of

climate chambers with workspace
ranging from 34 L to 2000 L, as well
as custom-sized walk-in test chambers, are
available for the execution of stability tests.
In specific cases, a stability chamber can be
adapted to the actual space that is available.

Documentation

Qualification

or recording the measurement values

of temperature and humidity, numerous
documentation options are available in
accordance with the respective requirements.
Each of these options is available with
independent sensors and, upon request, with
the control loop sensors.
In detail these options are as follows:
Analog line recorder
(paper line recorder)
Digital line recorder (line recorder with
memory and display)
Digital line recorder, complying with FDA
21 CFR Part 11 (line recorder with memory,
display and possibility of an electronic
signature)

Pharma software package

complying with FDA 21 CFR Part 11
for connecting devices and test chambers
to a PC.
Additionally, any existing temperature
or climate devices can be connected to
independent recorders or computers using
our
Pharma software which
complies with FDA 21 CFR Part 11.

Homogeneous
Airflow

Independent
Monitoring Center

pproval of active substances and/or

providing evidence of stability tests
requires numerous measurements that
have to be carried out and confirmed over
extremely long periods of time. To provide
evidence of compliance with fluctuations in
temperature and humidity, it is necessary to
ensure the flawless functioning of stability
test chambers.
These requirements are documented in
a sustainable manner by means of our
extensive qualification documentation.
The qualification system is comprised
of:
FAT
A2LA
DQ
IQ
OQ
PQ

Factory Acceptance Test

Calibration Certificates
Design Qualification
Installation Qualification
Operation Qualification
Performance Qualification

In addition to this we provide all the required

documents such as circuit diagrams,
component lists and certificates, e.g. ISO
accreditation, maintenance recommendations,
etc.
Our trained technicians not only carry out
on-site qualification on request, but can
also utilize the extensive measurement and
calibration facilities of our A2LA accredited
calibration laboratory. Please contact
Envirotronics for more information.

Reliability

Guaranteed

Calibration

Training

Service and Maintenance

hether it is maintenance, calibration

or repair, we are available to
quickly respond to your needs
through our sevice department.

arious Quality Assurance systems

require calibration and monitoring
of test equipment that can be traced
back to standards which are approved both
nationally and internationally.

ur competent staff would be pleased

to advise you on any questions you
may have relating to stability testing,
qualification, and documentation, as well as
questions relating to environmental simulation
and heat technology.

For this reason, Envirotronics, accredited

by A2LA according to ISO/IEC
17025:2005, provides calibrations and
calibration certificates for the measurable
variables of air temperature, dew point
temperature and relative humidity.

We will work with you to ensure that a

qualified service technician will be on site
to respond to your requirements as quickly
as possible after we have received a failure
notification.
As specialists in the fields of refrigeration,
climate and control technology, our
technicians are familiar with all the functions
and components of your system.

International acceptance of the A2LA

calibration certificates is underlined by the
membership of A2LA in ILAC (International
Laboratory Accreditation Cooperation), all
member countries of which must recognize an
A2LA calibration certificate.
Our trained calibration technicians
can perform calibrations and spatial
measurements of temperature and humidity
both in our factory as well as on site.

Every technician carries an extensive

inventory of spare parts. We also forward
spare parts to our technicians and customers
every day to ensure availability of the best
possible supply of parts.
We can offer training on all current topics
relating to our product range and its
application regularly, both in-house and onsite (e.g. FDA 21 CFR Part 11 in practice).
This team also qualifies and trains our service
technicians in regular on-the-job-training for
performing service, maintenance, calibration
and qualification.

Our extensive service network guarantees that

we will always be able to respond when you
need us.
Whether we assist you from our service center
or directly at your site our customers are
always given top priority.

Solutions

Test Laboratory

Application

hen testing the stability of drugs

according to the ICH (International
Conference on Harmonization)
guidelines, products must be stored under
defined climatic conditions.
The test systems Pharma600, Pharma1300
and Pharma2000 were specially developed
for use in laboratories and supplement the
spacious walk-in chambers that are used in
production areas.
Solutions for the Laboratory
Storage areas of
2.07 m2 (600 L)
4.14 m2 (1300 L)
6.21 m2 (2000 L)
with 6, 12 or 18 standard shelves
(additional shelves are available as an
option)
The functionality of the cabinets satisfies
the basic requirements of the official
guidelines as well as the demands of special
applications.
The chamber humidification is accomplished
through a patented system (Sterile Steam
System) which is monitored by an electronic
module. The water evaporation is done
at 140 C. The temperature and relative
humidity parameters are detected by a PT100
and a capacitive humidity sensor.
The test chamber is equipped with
, a powerful 32bit control system for monitoring and
controlling.
The MINCONTROL terminal with LCD-display
offers input and display of values and states.

Standard Equipment
Microprocessor monitoring and control
with
with terminal
MINCONTROL
Serial interface RS 232
Humidity input and display in % relative
humidity
Independent adjustable temperature limiter
tmin/tmax
Calibration of 2 temperature and 2
humidity values with certificate
Air-cooled refrigeration unit
Patented steam humidification
(Sterile Steam System)

Capacitive humidity sensor

Entry port 50 mm
Stainless steel interior
Water tank (19 L), manual and automatic
water supply possible
Door switch
Single wing door, lockable
Mobile on rolling wheels
Shelves 6, 12 or 18 pieces
(depending on workspace volume)

Requirements

Tailored to Your

Important Options
Color touchscreen

or
Pharma
software
Networking (RS 485 interface)
TCP/IP interface
Registration of temperature and humidity
Independent sensor for temperature and
humidity
Audible and visual warning signal
Water-cooled refrigeration unit
Glass door, heated
Feet, separately adjustable in height
Additional shelves
Additional entry ports
Demineralization unit for connection to
local water supply
Qualification documentation
Special voltages

Technical Data
Type
Shelves 650 x 530 mm
Storage space standard
Temperature range
Temperature deviation in time
Temperature deviation in space
Temperature gradient 1)
Humidity range
Humidity deviation in time
Calibrated values
External dimensions

Pharma600
piece
m2
C
C
C
C
%
%

Pharma1300 Pharma2000

6 3)
2.07 3)

12 3)
18 3)
3)
4.14
6.21 3)
+10 to +50
0.1 to 0.5
0.5 to 1.0
1 to 2
20 to 90
1 to 2
+25 C / 60 % RH and +40 C / 75 % RH
Width
mm in
740
29.1
1460
57.5
2155
84.8
Depth
mm in
1050
41.3
1050
41.3
1050
41.3
on wheels (standard)
Height mm in
1975
77.8
1975
77.8
2067
81.4
on feet (option)
Height mm in
2030
79.9
2030
79.9
2112
83.1
Test space dimensions
Width
mm in
620
24.4
1340
52.8
2034
80.1
Depth
mm in
685
27.0
685
27.0
685
27.0
Height mm in
1300
51.2
1300
51.2
1300
51.2
Entry port
mm
1 pc. 50 mm diameter, located on right wall
in
1 pc. @ 2 in diameter, located on right wall
Electrical connection
1/N/PE AC 230 V 10 %, 50 Hz
Rated power
kW
2.5
3.0
3.5
Weight
kg
150
250
350
dB(A)
52
52
52
Noise level 2)
Humidity water
demineralized water, pH value 6-7
conductivity 5 to 20 Microsiemens/cm
Performance values refer to +25 C ambient temperature - 1) In accordance with IEC 60068-3-5. 2) Free field,
1 m distance from the front, as per DIN 45635, part 1, accuracy class 2. 3) Additions possible.

Solution

Well find you a

ur slogan, well find you a Solution

says it all about what we do here at
Envirotronics.

We find solutions for our customers

environmental test chamber requirements
through innovative and intelligent
design, quality customer service, and our
commitment to excellence.
The images shown here represent a sample
of the equipment solutions we provide for
our customers. We would be delighted to to
discuss your test chamber requirements and
how Envirotronics can provide a successful
solution for you.
Let Envirotronics find a solution for you!

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ENV 1208 PH

3881 N. Greenbrooke SE Grand Rapids, MI USA 49512

Tel (800) 368-4768 (616) 554-5020 Email [email protected]
Fax (800) 791-7237 (616) 554-5021 Web www.envirotronics.com