Single Basket Tablet Disintegration Tester
Fully Automated Tablet Disintegration Testing
- Pharma Test - PTZ-S
EP <2.9.34>, DIN EN ISO 787-11 et ASTM B527
- Fully USP <701/2040> and EP <2.9.1/2.9.2> compliant
- Temperature adjustable within about 30 to 45°C
- Digital LED display of elapsed testing time and auto stop at the end of a run
The PTZ-S is used for the manual testing of disintegration times of tablets, capsules and other solid dosage forms.
The PTZ-S is a manual tablet disintegration testing instrument, manufactured according to the recent USP <701/2040>, EP <2.9.1/2.9.1.2>, JP and other pharmacopoeias. The PTZ-S is used for the manual testing of disintegration times of tablets, capsules and other solid dosage forms.
Features
- Fully USP <701/2040> and EP <2.9.1/2.9.2> compliant
- Temperature adjustable within about 30 to 45°C
- Digital LED display of elapsed testing time and auto stop at the end of a run
- Single and triple station (DIST-3) instruments available
- Exchangeable baskets for apparatus “B” (30mm tube size) as described in the USP <2040> and EP <2.9.1.2>)
- GMP compliant stainless steel housing
Advantages
- LED display informing of running time and firmware version
- Totally silent operation of the stroke mechanism
- Pre-programmable maximum disintegration time with Auto-Stop function
- Vibration free movement, stroke height set to 55 mm at 30 strokes/min
- Disintegration basket always stops at highest point
- Built-in heating system includes overheating protection
- Small footprint: approx. 42 x 26 x 42cm (width x depth x height)
Operating Mode
The single basket PTZ-S version offers the following features: The illuminated digital LED display shows the elapsed testing time and the firmware version. A silent 24V DC motor drive smoothly moves the disintegration basket up and down over a distance of 55 mm (each way),30 times per minute. Every two seconds the stroke rate is automatically re-adjusted; the stroke height is pre-set by the eccentric drive mechanism. The disintegration basket which holds the glass tubes and discs, is placed into a stainless steel holder. After start it is smoothly moved into the testing medium. Depending on the operating procedure, the test is either automatically stopped if the pre-set time has expired or if the operator aborts the test after he saw all samples to be disintegrated. The basket always stops at its highest mechanical position.
Standard Disintegration Basket
The standard disintegration basket is supplied with 6 glass tubes and 6 plastic discs. Optionally, the 3 tube basket for larger samples according to apparatus “B” of the EP <2.9.1.2> and USP <2040>, can be used without any further modifications.
Heating System and Mechanical Features
A built-in thermostatically controlled heating system warms the water within the Plexiglas (Perspex) bath up to 37°C. A powerful pump is used to circulate the water within the bath. The pre-selected temperature is automatically adjusted by a built-in control sensor. A second sensor is used as a safety device which switches off the heater should the temperature rise outside the limit. A thermo fuse and a thermo switch, fixed to the heater, provide additional safety features to protect the system from overheating. The bath temperature can be stepplessly adjusted. Using an external control thermometer the temperature of the test medium can be checked at any time.
Technical Specifications
Parameter | Specifications |
---|---|
Display | LED, illuminated |
Data Entry | Functional keys |
Testing Positions | 1 basket for 6 samples (alternative basket for 3 larger samples available) |
Timer | 1 sec. up to 9 hrs. 59 min. 59 sec. |
Stroke Height | Fixed at 55mm |
Stroke Frequency | 30 strokes / minute |
Temperature Adjustment | Set to 37°C, adjustable by potentiometer between approx. 30° and 45°C |
Instrument Housing | Stainless steel, powder coated surface for better material protection |
Instrument Dimensions | Approx. 42 x 26 x 42cm (width x depth x height) |
Packaging Dimensions | Approx. 60 x 48 x 62cm (width x depth x height) |
Net / Gross Weight | 12 / 18kg |
Certification | All components certified to USP/EP requirements |
CE/EMC Certification | All CE/EMC certification provided |
Validation | All IQ & OQ documents included |
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