The PTWS 1210 6+6+2-station Dissolution Bath is

The PTWS 1210 6+6+2-station Dissolution Bath is
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
Staggered or simultaneous stirrer start, manual or automated operation is offered by the advanced
ADS-PTWS1210 System. It includes an Ismatec Multi Channel Peristaltic Pump and a SA500 UV/VIS
Diode Array Spectrophotometer or a any other suitable UV/VIS Photometer with minimum 12-cell
changer. The fully automated closed loop Tablet Dissolution Testing System is controlled by the
WinDiss32 Software Suite which is fully 21CFR Part 11 compliant.
The PTWS 1210 6+6+2-station Dissolution Bath is equipped with the EPE Auto-Sampling
Manifold and a manual Tablet Drop Magazine. The added advantage of the EPE option is
that the sampling probes are only in the dissolution medium when sampling is required. The
EPE is raised out of the bath after the sampling sequence is complete. This fulfils the other
school of thought that sampling probes should only be in the solution for a minimum period
so as to avoid unnecessary solution perturbation. Each sampling tube may be fitted with 5 or
10 micron in-line filters so as to avoid the passage of insoluble excipients into the
measurement cells inside the spectrophotometer. Using the Tablet Drop Magazine all 12
samples are dropped at the same time into the Dissolution Vessels for simultaneous
sampling and measurement. Teflon tubing is connecting the Dissolution Vessels via an 16
channel Peristaltic Pump (IPC16) to the Photometer with its built-in 16 cuvette changer. All
instruments are controlled by the WinDiss32 Software which has to be installed to a suitable
PC.
As with nearly all sampling systems re-usable in-line filters are attached to the sampling
tubes which are only placed in the dissolution vessel while sampling whenever the EPE
Sampling System is used. Sampling position, distance and dimensions are according to the
USP directive which states that the sampling point must be exactly half way between the
dissolution medium surface and the top of the stirring tool (Paddle, Basket or TD cylinder). At
the appropriate pre-programmed time the EPE will drive down into sampling position, the
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
page 1 of 15
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
pump will be switched on and the sample tubing lines to the cuvettes are filled. The pump will
be stopped and the spectra measured are transferred from the spectrophotometer to the
WinDiss32 Software for further processing. Also stirring speed, bath and media temperature
(optional), sampling and measuring time are logged.
The ADS 1210 can also be fitted with an optional online temperature monitoring device ITM
connected to the EPE system. This will monitor and log the actual media temperature inside
the dissolution vessels while sampling.
As the PTWS 1210 is fitted with 12 vessels, then cuvette 14 can be filled with a fresh
Reference Standard. Cuvette 13 is connected to vessel 13 which may hold Blank Media.
One or both can be measured each time prior to the measurement sequence. This has an
advantage in that minor variations in absorbance values encountered over a series of
measurements can be compensated for as each set of measurements is made relative to a
Reference Standard which has been treated in exactly the same way as the samples. At the
end of the pre-programmed sequence, the dissolution / time profile as well as the final
concentration of active in solution may be displayed or printed prior to storage.
Operating Principle:
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
page 2 of 15
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
On-line Systems
Using an automated Dissolution System is offering a good number of advantages, such user
free sampling, on-line measurement of drug absorbance, accurate sampling timing, precise
sampling positioning both either using an inside media sampling probe (insitu) or a removing
EPE sampling system which remains only inside the media as long as sampling takes place.
Also data correction, using the on-line Standard and/or Blank Media and automated result
calculation will save time and offer highest quality data presentation.
This popular configuration is elaborate, but allows real time calculation of results using the
new fully 21 CFR Part 11 compliant WinDiss32 software and is by definition PC controlled.
The overall structure of both software packages and their programming options is described
in our WEB publication called: Dissolution Automation: Key points for Consideration
With this multi-cell changer configuration, the basic automation elements are entered into the
program structure. This data, once installed will cause the software to further interrogate the
user as to the configuration of the automation elements. Taking the spectrophotometer as an
example, the program needs information as to whether there is a cuvette changer or not and
if so, then is it a 6, 8 way or even 16 way. This is vital information as the Blank Medium has
to be compared to the reference cell, and zeroed at the appropriate wavelength. This is done
on cell 7, 14 to 16 with an 8- or 16-cell changer as this positions are usually connected to the
Blank Media Vessel. The Standard Media (for concentration calculation) is usually in cell 8 or
15 to 16. This means that the medium can be compared to the reference cell and zeroed at
the start of each measurement sequence. After the zero has been established the
measurement sequence is then cell 8 (Reference), followed by cells 1 to 7 or to 16.
What is an ADS-PTWS1210 system?
The ADS system offers an auto dissolution package incorporating validated systems. A state
of the art Dissolution Bath Type PTWS 1210 with 12 vessels. Incorporated tablet drop
magazine and removable sampling manifold EPE. A PDA Diode Array SA500 Diode Array
UV/VIS spectrophotometer with 16 cell changer of any other branch with a suitable cell
changer is possible to be connected into the system if equipped with 16-cell changer, 16
channel peristaltic pump equipped with Ismaprene tubing. Teflon based sampling systems
which are transferred from the vessels via the peristaltic pump to the spectrophotometer and
the inside flow cells and back to the vessels (closed loop). There will be no crosscontamination ob volume loss due to the individual closed loop system design. Using the
PTWS 1210 and EPE Auto Sampling System the sampling probes are being removed after
each sampling sequence.
The flow cells which have to be used are available with different path length to suit your
measurement needs. Depending on the maximum concentration you will be able to use cells
from 20 mm (SA500 only) and common 10mm path length down to 0.1 mm which
corresponds to a dilution factor of 1:200 compared to a manual sampling procedure.
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
page 3 of 15
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
The Photometer
We offer different Spectrophotometer Drivers which may be incorporated into the ADSPTWS1210 Auto Dissolution Test System. Depending on the application the system should
be used for the user may select between single beam and double beam Photometers or
Diode Array Detectors.
The use of a single or double spectrophotometer is possible if only single or multiple
wavelength tests with now timing problem have to be performed. As soon as measuring
speed or spectra scanning should be done we recommend the use of a PDA Diode Array
UV/VIS Spectrophotometer.
Any of the possible Spectrophotometer Types which can be included needs to be equipped
with a 12 to 16-cell changer. The cell compartment should have enough space to connect the
required Tubing and allow free movement of the cell changer during operation.
The SA 500 Diode Array Spectrophotometer
If a SA 500 Diode Array Photometer is included into the system all major components are
made and supplied by us which mean trouble free and reliable operation during the full live
cycle of the system. The SA 500 has a built in 16-cell changer. The cell changer
compartment is not covered and is therefore easy to access. Thanks to the cell holder
design, all of the installed UV cells are correctly positioned in the light path. The use of fibre
optic light transmission allows an optical system design without moving parts. A fibre optic
beam coupler eliminates the requirement for mirror switching at the light source (change from
D2 to Tungsten lamp) as found in conventional spectrometers. The overall result is improved
reliability and long term system stability.
The cell holder will take flow-cells with a maximum path length of 20 mm and cells with a
path length down to 0.1 mm.
The specially developed fibre optic technology used in the SA 500 is combined with a unique
diode array detection module to give a unit which features very low energy losses compared
with conventional optical systems.
These higher energy levels permit more rapid scanning of the array than is found in more
conventional detectors resulting in a much faster scanning capability for a given signal to
noise ratio. This is the only technology which allows real time data acquisition of complete
spectra at very high speeds, e.g. in ≈12 milliseconds.
WinDiss32 Software
The CFR 21 Part 11 compliant WinDiss32 software drives the system and collects the
results. In includes system operation log file, audit trail, user access right administration,
password protection and administration, electronic signature, report generator etc. It offers
single or multi-component analysis.
The ADS System components are controlled and integrated into WinDiss32 Dissolution Data
management software which is used by the worlds largest Pharmaceutical companies.
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
page 4 of 15
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
Driver Linkage with Unique Solution Path Technology
•
WinDiss32 Supports a wide range of Baths, Auto
samplers, Fraction Collectors, Pumps, and other
Detectors
•
It uses a Unique Solution Path Technology
•
Configuration for different analysis requires no additional
reprogramming.
•
Support for Closed and Open Loop for UV and HPLC
systems.
•
WinDiss32 can operate with USP I, II, III and IV
methods.
•
Expanded capability for HPLC
•
Collect and store samples in Auto samplers to perform
online dilution, mixing and measurement on the ADS.
PTWS
Data collection rate:
The user can enter multiple data collection times during the entire dissolution run thus
allowing more data points when active dissolves quickly and less towards the end of the
profile.
FDA 21 CFR part 11 Compliance
The WinDiss32 Administration allows the system
administrator to enter details of users to access
the system. The user Logon name, full name and
password are configured for each user with Group
or individual access rights.
Individual access to the system is by a unique
user name and password and the users full name
is displayed whenever the user logs on
successfully.
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
page 5 of 15
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
Configurable Centralised Security
The Global Settings allow the administrator to set limits to prevent unauthorised access to
the data station, Password expiry, Log Off Times etc for each access level.
These activities can be performed remotely from any WinDiss32 networked workstation.
WinDiss32 provides the user with total management of the signing process, from start to
finish. This includes configuring the number of signing levels, the Users for each level,
Signer Activity and Meaning.
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
page 6 of 15
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
Signing and Reporting Signed Records
Once data is acquired in a Group with signing rights, any report generated will show the
signing status for all pages of the record shown on the report.
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
page 7 of 15
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
Dynamic Report Editor
The WinDiss32 report organizer allows users to produce customized reports with the right
information by selecting from a combination of objects such as Method Header, Data Tables,
Method Parameters, Graphs and the Company Logo.
These details may include any parameter measured during the test such as bath
Temperature, Paddle speed, Time Intervals as well as Absorbance, Concentration and %
Dissolved.
Any number of pages can be selected with automatic page numbering.
Standard Report Format Graphics Printer
WinDiss32 is supplied with a Graphics Printer that provides compliance with 21 CFR Part 11
requirements for “human readable form”.
These reports can be circulated, emailed etc., in the safe knowledge that they are noneditable.
This Graphics Printer can capture any report into TIF, BMP or JPG (JPEG) and save them as
electronic files.
The TIF format can save a multiple page report and the Image Viewer supplied automatically
displays the printed file image for verification.
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
page 8 of 15
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
User Queryable Audit Trail
WinDiss32 Audit Trail lists all user activity that creates, deletes or modifies; i.e., from logging
on and off to editing of method and data records.
This Audit Trail can be queried to limit the volume of information from a search and the
results from any search can be printed.
Networking
Our networked system provides a central relational database that contains all data (methods
and data records) from all WinDiss32 workstations. Details are accessible from any station
linked to the networked database.
Each system runs from a workstation PC, as each hardware configuration can be unique.
This configuration allows Data records to be signed remotely by users from clients. For
example, it is now possible for analysts and supervisors or managers to view, sign, print etc
away from the laboratory area.
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
page 9 of 15
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
Keeping the cost sensible….
We, at Pharma Test have opted to take the work out Spectrophotometer selection and
accessory hunting by offering complete upgrade systems for existing Dissolution Baths which
have not only differing degrees of sophistication but which also offer affordable options to
cover all budgets.
Bath Drivers Available:
PHARMA TEST:
Others:
PTWS 310, PTWS 600/1200, 610/1210 and DT series
Varian, Sotax, Erweka, Distek (ask for details and
models to be included)
Photometer Drivers Available:
PHARMA TEST:
SA 500 PDA Diode Array Photometer incl. 8- or 16-cell
changer, T70 Split-Beam UV/VIS Photometer incl. 8-cell
changer
AGILENT:
8453 PDA Diode Array Photometer incl. 8-cell changer
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
page 10 of 15
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
PERKIN ELMER:
Lambda 2/10/20 incl. 8-cell changer
Lambda Lambda 25/45 incl. 8- or 16 cell changer
VARIAN:
Carry 50 incl. 8- or 18-cell changer
CECIL:
CE 2000, 3000, 5000, 6000, 8000 and 9000 series incl.
8-cell changer
JASCO:
UV 500 incl. 8-cell changer
BECKMAN:
DU 600, DU 7000, DU 9000 series incl. 8-cell changer
ANALYTIK JENA:
SPECORD incl. 8 or 16 cell changer
THERMO Scientific:
EVOLUTION, incl. cell changer
Technical Data of the spectrometer will be listed in the quotation
Pump Drivers Available:
Ismatec:
Watson Marlow:
CAT:
IPC 8, 16, 24
PT-P80, PT-P160
CAT 8 Piston Pump
Technical Data
PTWS 1210 Dissolution Bath, 1 litre version (2 litre system available too)
Number of Stirring Positions:
Stirrer Speed:
Stirrer Design:
Vessels:
Vessel Centring:
Thermostat:
Temperature:
Wake Up:
Vibration Absorber:
Water Bath:
Standard Supply includes:
Sampling System:
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
12
Adjustable within 25-250 rpm, accuracy ± 1rpm
Mono Shaft stirrers and stirring tool adapters. When
immersion depths is set once no need to repeat when
stirrer adapter has to be changed
Individually batch coded 1 litre USP/EP graduated glass
vessels
Auto-Centring System for each vessel
Built in circulating pump, spring loaded for vibration free
operation and 1000 W heater
Adjustable within 25-45.0°C, accuracy ± 0.3°C
Programmable wake-up time including heater start
The water bath is placed onto 4 Vibroban vibration
absorbers, measurable vibration at the vessels less than
0.25 µm displacement
U-shaped Plexiglas water bath with PP cover and drain
cock, built-in water diffuser for faster heating up times
8 stainless steel mono shaft stirrers, 8 stainless steel
Paddle blades, 8 USP glass vessels, depth and centring
gauge,
EPE auto sampling system including 10 micron PP
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
page 11 of 15
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
Tubing Installation:
Tablet Magazine:
Cleaning Assistant:
Documentation:
sinter filter attached to each sampling ferrule
Teflon Tubing using fast connectors, tube internal diam.
1.0 mm for low volume outside the dissolution vessels
manual or automated tablet drop magazine introduces
tablets simultaneously when system ready for test
Plexiglas plate holding 8 cleaning beakers to be used to
flush all tubing and cells when test is finished
Includes User Manual, IQ and OQ Documentation
PT-PS80 Peristaltic Pump
CAT 8 Piston Pump
Ismatec IPC Pump
Peristaltic Pump IPC 16 channel
Pump Tubing:
Pump Speed:
Accuracy:
Pump Channels:
Interface:
Documentation:
Ismaprene ENE 021
adjustable, typical flow rate for dissolution approx. 5
ml/min
depends on pump tubing, usually ± 5 % of volume rate
16
RS232 or TTL
Includes User Manual, IQ and OQ Documentation
CAT 8 Piston Pump
Number of channels:
Pump head type:
Material:
Stroke volume of pump head:
Minimum flow rate:
Maximum flow rate:
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
8 (2 CAT pumps are requested in this case)
200VCS
stainless steel, silent version
approx. 200 micro litre
0.15 ml/min.
20 ml/min.
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
page 12 of 15
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
Accuracy and precision:
Pump connection:
Tubing:
Interface:
Documentation:
< 1% over full range, excluding external factors such as
tubing etc.
1/4-28" UNF for PTFE connectors
1.0 mm ID, 1.6 mm OD PTFE/FEP (tubing not included)
Rinse pump type HPLV 20V is included and is
connected to all 8 pump heads
RS-232 and I/O port
Includes User Manual, IQ and OQ Documentation
SA500 Diode Array Photometer
Optical System
Light Source
Lifetime:
Wavelength Range
Maximum measurement speed
Number of Diodes
Optical Grating
Spectral Resolution
Spectral Bandwidth
Wavelength Accuracy
Wavelength Precision
Noise (at 580nm)
Baseline Drift
Temperature Drift
Scattered light:
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
D2 and Tungsten lamps
D2 lamp has a life of approx. 1500 hours
190 - 1020 nm
12 milliseconds / Spectrum
1024
248L/mm
0.8 nm/Pixel
1.6 nm
0.3 nm
± 0.07nm
± 2.5 x 10-5 AU
5 x 10-4 AU
< 0.005nm / °C
< 0.1% @ 340nm (D2 lamp)
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
page 13 of 15
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
Data Integration:
Flow cell compensation:
Communication Port :
Multiple Cell Changer:
Flow Through Cells :
Data integration time approximately 100ms per channel
Work with either absolute or baseline corrected
absorption data
Ethernet and RS232
16 cells (max. path length 10 mm)
0.1 - 0.2 - 0.5 - 1.0 - 2.0 - 5.0 - 10.0 mm path length
(not included in the supply scope)
Setup
Electronic system
The SA 500 uses a very fast RISC Processor and processes the raw spectral data within the
unit. All data storage and post processing is then via an external PC.
Documentation
Includes User Manual, IQ and OQ Documentation
WinDiss32 Software
- Design System components
- Create and file Testing Methods including instrument control data
- Program single ob multiple calibration data
- Select single or multi component analysis
- Read single, multiple wavelength or full scan
- File all data immediately after collecting (no information loss at all)
- Operate Single- or Dual Systems
- Includes User Manual, IQ and OQ Documentation needs to be ordered
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
page 14 of 15
Fully Automated Tablet Dissolution Testing System- Type ADS-PTWS1210
Available ADS System Options
- Select other PTA Dissolution Bath or even use existing instruments
- Select other UV/VIS Spectrophotometer having multiple cell changer
- Operate 12 vessel or dual bath systems
- Include Auto Sampler for sample dilution or sample processing prior to injection and
measurement
System Validation
System validation can be done using the USP Reference Standard (RS) Tablets and
Standards. Supply scope includes full IQ/OQ documentation for the supplied hard ware.
Installation and Qualification
The dissolution system installation and qualification may be performed at installation by a
Pharma Test trained engineer or agent. All IQ and OQ paperwork supplied as standard.
Powerful dissolution result reporting software to generate individual report sheets including
both results and graphics.
WinDiss32 is installed under Windows NT or 2000, XP™ (GB or US Version)
Other factors influencing Dissolution Rates.
Below are some interesting statistics covering various things which may influence the results
of a typical dissolution test run. Some influences are quite small but others, such as
degassing the dissolution medium, are quite dramatic (ask for the PT-DDS Medium
Degassing and Preparation Instrument brochure):
Factors affecting the PQ results:
Type
Rating
influence degree
Temperature
Speed
Vibration
Centricity
Dissolved Gas
Media pH
Media Contamination
Sampling Position
not too significant
significant
significant
reasonable
significant
reasonable
significant
not too significant
linear
10-30%
10-40%
± 5-15%
± 50%
± 5-10%
± 20-45%
± 5-10%
We reserve the right to make technical changes without any prior notice
PHARMA TEST AG
Siemensstrasse 5
D-63512 Hainburg (GER)
38-04551_ADS1210_09.1.0E
+49 6182 9532-600
+49 6182 9532-650
[email protected]
www.pharma-test.com
page 15 of 15
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertisement