Dissolution tester Pharma test Gemb H Germany Pharmaceutical

Dissolution tester Pharma test Gemb. H (Germany)

연구 및 개발부 Pharmaceutical oral dosage form (tablet, etc. ) In vivo Drug release Dissolution Characteristics (time, where is the dosage form dissolving, dissolution curve etc. ) ?

약전에 주어진 규격 Stirring Speed (± 4%) Shaft Material, Size and Wobble Media must be deaerated Sampling Position Vessel Material and Dimension Centring of Stirring Tool Paddle Dimension Paddle Position Temperature (37 ± 0. 5 °C)

용출 결과에 영향을 끼치는 인자들 Type Rating Influence degree Temperature Not too significant linear Speed significant 10 -30% Vibration reasonable 5 -10% Centricity reasonable ± 5 -15% Dissolved Gas significant ± 50% Media p. H reasonable ± 5 -10% Media Contamination significant ± 20 -45% Sampling position Not too significant ± 1 -3%

기계적인 인자의 calibration Calibration parameter Usp 24 tolerances Point of measurement Proposed tolerances Proposed frequency Height check 25± 2㎜ Paddle/basket bottom 25± 2 ㎜ At time of use if vessels are removed Basket wobble ± 1 ㎜ as run out Bottom of basket rim ≤ 1. 0 ㎜ total run out Every 3 months Rotational speed ± 4% Not applicable ± 1 rpm Every 3 months Vessel/shaft centering 2 ㎜ from center line Center line 2 ㎜ from center line Every 3 months Vessel temperature 37± 0. 5°C Not applicable 37± 0. 5°C At time of use Bath level Level Base plate Level Every 3 months Shaft wobble no significant wobble 2㎝ above top of paddle blade ≤ 0. 5 ㎜ total run out Every 3 months Paddle/basket dimensions See USP Upon receipt

Vessel dimensions See USP Upon receipt Degassing technique NCDA 2 passes calibration Not applicable NCDA 2 passes calibration Once per year No gross defects as determined by visual inspection At time of use Proposed parameters under investigation Paddle/basket examination None Not applicable Shaft verticality None Above vessel Vertical as measured by Every 3 months a bubble level Visual inspection of belts; check ball bearings None Not applicable Belts are tight, clean, free of cracks, properly aligned; shaft turns freely Every 3 months Vibration None Base plate while operating at 100 rpm ≤ 0. 2 mil Every 3 months

약전에 의한 용출법 Apparatus 1 Used for Tablets, Capsules, especially when the media is changed during the test run Apparatus 2 Standard Apparatus, used for solid dosage forms Apparatus 3 Bio. Diss: Used when the medium and the p. H is changed continuously Apparatus 4 Used for lipophilic solid dosage forms suppositories and soft capsules

Apparatus 5 Disks and Extraction cells are used to test transdermal patches. Apparatus 6 The Rotating cylinder is used to Test Transdermal patches. PTSWO: Special Tester for Suppositories, Soft Gels and similar products

탈기, 용매의 제조 • • • “The United States Pharmacopoeia (USP)” recognises that dissolved gases in the Dissolution Media may affect Dissolution Test Results and recommends that gases should be removed before the test is performed” (USP 23/NF 18) Prepared Medium to reproducible standards USP prescription of : Heating, Circulating and Vacuum The Temperature of the Media must be in the range of 37 +/- 0, 5 °C

탈기의 중요성 Particle with associated air bubble. The dissolution process is highly influenced.

Media preparation system

PT-DDS 4

용출기의 구성 실례 1. Auto sampling system 2. Flow through cell

3. On-line UV analyze 4. On-line LC analyze

Pharma test 용출기의 우수점 • Vibration absorber

• Drawer • Staggered Start • PHARMA TEST offers a staggered start feature since more than 28 years now. • Stirrer clamp screw

• Stirrer drive • Built-in Printer • A built-in printing center which will print a Test Log (speed, temperature, sampling sequence, detected errors) but also a PQ slip which can be used to record the Qualification Results of the Dissolution Bath