How many Tablets shall be taken for checking friability?
- For tablets with unit mass equal or less than 650 mg, take a sample of whole tablets corresponding to 6.5g.
- For tablets with unit mass of more than 650mg, take a sample of 10 whole tablets.
What is the pass or fail criteria for the friability test?
- Generally, the test is run once. If any cracked, cleaved or broken tablets are present in the tablet sample after tumbling, the tablets fail the test. If the results are doubtful, or weight loss is greater than the targeted value, the test should be repeated twice and the mean of the three tests determined. A mean weight loss from the three samples of not more than 1.0% is considered acceptable for most of the products.
What is the standard number of rotations used for the friability test?
- 100 rotations
What is the fall height of the tablets in the friability during friability testing?
- 6 inches. Tablets fall from 6 inches in height in each turn within the apparatus.
Why do we check hardness during in-process checks?
- To determine the need for pressure adjustments on the tableting machine. Hardness can affect the disintegration time. If the tablet is too hard, it may not disintegrate in the required period of time. And if a tablet is too soft it will not withstand handling and subsequent processing such as coating, packing etc.
What is the formula for calculating weight loss during the friability test?
What are the factors which influence tablet hardness?
- Compression force
- Binder quantity (More binder more hardness)
- Moisture content
Which type of tablets are exempted from Disintegration testing?
- Chewable Tablets
Which capsule is bigger in size - size '0' or size '1'?
- '0' size
What is the recommended temperature for checking DT of a dispersible tablet?
- 25 ± 10°C (IP) & 15 – 25°C (BP)
What is the mesh aperture of the DT apparatus?
- 1.8 -2.2 mm (#10)
List out the appearance defects of tables during compression activity?
- Capping: ‘Capping’ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling.
- Lamination / Laminating: ‘Lamination’ is the separation of a tablet into two or more distinct horizontal layers.
- Sticking/filming: ‘Sticking’ refers to the tablet material adhering to the die wall. Filming is a slow form of sticking and is largely due to excess moisture in the granulation.
- Cracking: Small fine cracks observed on the upper and lower center surface of the tablets, or very rarely on the side wall are referred to as cracks.
- Chipping: ‘Chipping’ is defined as the breaking of tablet edges, while the tablet leaves the press or during subsequent handling and coating operation.
- Mottling: ‘Mottling’ is the term used to describe an unequal distribution of colour on a tablet.
- Double Impression: ‘Double impression’ involves only those punches, which have a monogram or other engraving on them.
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What are the pass/fail criteria for the disintegration test?
- If one or two tablets/capsules fail to disintegrate completely, repeat the test on another 12 additional dosage units. The requirement is met if not fewer than 16 out of 18 tablets/capsules tested are disintegrated completely.
What are the recommended storage conditions for empty hard gelatin capsules?
- 15 - 25°C & 35 -55% RH
Which method is employed for checking “Uniformity of dosage unit”?
- Content uniformity
- Weight Variation
- Weight variation is applicable for the following dosage forms; Hard gelatin capsules, uncoated or film-coated tablets, containing 25mg or more of a drug substance comprising 25% or more by weight of dosage unit.
What is the recommended upward and downward movement frequency of a basket-rack assembly in a DT apparatus?
- 28 – 32 cycles per minute.
When performing the dosage unit's ‘uniformity of weight’, how many tablets/capsules can deviate from the established limit?
- Not more than two of the individual weights can deviate from the average weight by more than the percentage given in the pharmacopeia, and none can deviates more than twice that percentage.
Weight Variation limits for Tablets
Weight Variation limits for Capsules
- Environmental Monitoring
- Measured values obtained from the process equipment (ex: temperature, RPM, etc.)
- Measured values obtained from persons (ex: timings, entries, etc.)
- Process attributes (Ex: weight, hardness, friability, etc.)
What precautions shall be taken while collecting in-process samples?
- While collecting in-process samples, avoid contamination of the product being sampled (Don’t collect samples with bare hands) & avoid contamination of sample taken.
In a tablet manufacturing facility ‘positive’ pressure is maintained in the processing area or service corridors?
- In tablet manufacturing facilities, pressure gradients are maintained to avoid cross-contamination of products through air. Usually, service corridors are maintained under positive pressure with respect to processing areas.
If sticking is observed during tablet compression what may be the probable reason for the same?
- If the granules are not dried properly sticking can occur.
- Too little or improper lubrication.
- Too much binder
- Hygroscopic granular
What checks shall be carried out while calibrating the DT apparatus?
- While calibrating the DT apparatus, the following checks shall be performed.
- Number of strokes per minute (Limit: 29-32 cycles/min)
- Temperature by probe & standard thermometer (Limit: 37 ± 1 °C).
- Distance traveled by basket (Limit: 53 -57mm)
What is In-process checks?
- In-process checks are checks performed during an activity, In order to monitor and, if necessary, adjust the process to ensure that the product conforms to its specification.
What is the difference between disintegration and dissolution?
- Disintegration is a disaggregation process, in which an oral dosage form falls apart into smaller aggregates. (Disintegration time is the ‘break up’ time of a solid dosage form).
- Dissolution is a process by which a solid substance enters in the solvent to yield a solution. It is controlled by the affinity between the solid substance and the solvent.
In other word disintegration is a subset of dissolution.
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What is the difference between calibration and Validation?
- Calibration is a demonstration that, a particular Instrument or device produces results within specified limits by comparisons with those produced by a reference or traceable standard over an appropriate range of measurements.
- Validation is a documented program that provides a high degree of assurance that a specific process, method, or system consistently produces a result meeting pre-determined acceptance criteria.
- In calibration performance of an instrument or device is compared against a reference standard. But in validation, such a reference standard is not using.
- Calibration ensures that instruments or measuring devices produce accurate results. Whereas validation demonstrates that a process, equipment, method or system produces consistent results (in other words, it ensures that uniform batches are produced).
Why do we calibrate qualified equipment/instruments at definite intervals?
- Equipment or instrument can ‘drift’ out of accuracy between the time of qualification and actual use. So it is recommended to calibrate and recalibrate the measuring devices and instruments at predetermined time intervals, to gain confidence in the accuracy of the data.
Why do we consider three consecutive runs/batches for process validation? Why not two or four?
- The number of batches produced in the validation exercise should be sufficient to allow the normal extent of variation and trends to be established and to provide sufficient data for evaluation and reproducibility.
- First batch quality is accidental (co-incidental),
- Second batch quality is regular (accidental),
- Third batch quality is validation (conformation).
- In 2 batches we cannot assure the reproducibility of data, 4 batches can be taken but the time and cost are involved.
Position of oblong tablets to be placed in hardness tester to determine the hardness? Lengthwise / widthwise?
- The position of oblong tablets should be length-wise because the probability of breakage is more in this position.
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