TABLETS Que: Is it easy to manufacture a “tablet” ? Ans: No…
Steps Of Tablet Manufacturing
Quality Checks During Manufacturing
IPQC Parameters to be measured I. Physical Parameters : a. temp b. time c. particle size & texture d. pressure mmH 2 O e. weight f. hardness g. thickness & diameter h. disintegration i. dissolution ( % release) j. friability k. moisture content %relative humidity
BMR for Tab Mfg Process Date Time Operation Room No. Temp °C %RH Diff. press (mm H2O) signature Dispensing 23 42 2.0 Sifting 48 1.8 Milling 2.0 Blending Compression Coating
Compression Parameters Parameter Limit Observation Machine speed 20 rpm (15-25 rpm) Wt. of 20 tabs 12.00g + 2 (11.76-12.24g) Theoretical weight/tab 600mg Hardness 25Kg (20-30 Kg) Thickness (av. of 10 tabs) 4.10mm + 0.15mm (3.95 – 4.25mm) Length 10mm + 0.1 mm (9.9 – 10.1 mm) Width 5 mm + 0.1mm (4.9 – 5.1 mm) Disintegration time NMT 15 mins Wt. variation + 3% of Av. Wt. Friability (10 tabs) NMT 1.0% w/w
IPQC checks frequency during mfg. Parameter Frequency Wt. of 20 tabs Every hour by production and every two hours by QA Hardness, thickness, length, width Every hour by production , every two hours by QA Wt. variation Every half hour by production and every hour by QA DT Every half hour by production , every hour by QA
Steps Of Capsule Manufacturing
Mfg of Gelatin Shell.
Drying of shells in controlled humidity.
Mfg of granules/spanzules.
Filling of Shells.
Packaging & Labeling.
IPQC Checks During Gelatin Shell Manufacturing
% purity of gelatin
Viscosity of gelatin solution 25-45 millipoise
Bloom strength of gelatin solution 150-250 gm
Iron content NMT 15 ppm
pH of gelatin A=9; B=4.7
Color, surface, appearance of empty shells
Temperature of hot air, for drying of shells
Length of Capsule & Body of the shell
Moisture content 12-15%
Sorting of defective shells
After the capsules have been inspected either
electronically or manually, they are sampled by the
QA inspector & checked for the defects and then
Printing inspection on shell
Inspection of defects like:-
Hardening of shells
Softening of shells
Swelling of shells
Cracking of shells
Discoloration of shells
Misprinting of logo on shells
IPQC Checks During Filling Of Empty Capsule Shells
During filling process equipment should be labeled
with :-product name, Batch No, Time of starting, Sign
During Filling: flow property of granules or powders
Weight Variation :
For hard gel caps -
Limit NMT 2 caps should deviate from avg wt.
AVG WT %DEVIATION
>300mg or more 7.5%
For soft gel caps:
Wg 10 caps
Remove inner content by cutting with scissor/blade
Wash with solvent & evaporate solvent at room
temperature for 30 min
Wg the empty shells & calculate % deviation
MACHINE OUTPUT INSPECTION:
Machine output is monitored in a specific time interval
Total batch or number of caps filled are counted in a
specific time interval & then machine is calibrated and
speed is maintained.
Inspection of capsules checked with a standard strip
Electronic automated or manual inspection is made to sort out & reject the defected caps.
PRINTING & LABELING:
Inspection of overprinting, logo, labeling are checked with the standard shade cards.
Defective ones are sorted out & rejected.
LOZENGES Que- Are they different from Tablets? Ans- Yes..