QUALITY CONTROL
AND PRODUCTION
AT
MEYER ORGANICS Pvt. Ltd.
QUALITY CONTROL
Chemist do a qualitative analysis to identify the substances in the
sample and to determine the quantity or concentration of a specific
substance in the sample.
Raw material analysis
Finished Products analysis
In-process Checks
Stability Studies
WET CHEMICAL ANALYSIS:
pH, loss on drying (LOD), Thin layer chromatography, Residue on ignition
(ROI), viscosity, sieve analysis, Tap density, Karl fisher titration,
Disintegration test, Dissolution test, tablet hardness.
INSTRUMENTAL ANALYSIS:
High Performance Liquid Chromatography (HPLC), Gas chromatography,
Atomic absorption spectroscopy, IR Spectrophotometer, UV
Spectrophotometer.
Dissolution test
Sieve plates Tablet hardness tester
Tap density Disintegration test Karl fisher titration
HPLC Gas chromatography
UV Spectrophotometer
tomic absorption spectroscopy IR Spectrophotometer
PRODUCTION
In addition to active ingredients, tablets contain a number of inert
materials known as excipients. Such as:
1. Diluent: used to improve cohesion and promote flow during compression.
Eg: Mannitol, sorbitol, dextrose.
2. Binders and adhesives: these are added either in dry or wet form to form
granules. Eg: gelatin, glucose, starch paste, sodium alginate.
3. Disintegrants: added to tablet formulation to facilitate its breaking or
disintegration. Eg: starch, cellulose, alginate.
4. Lubricants and glidants: these are added to prevent adhesion of the
tablet materials to the surface of the dies and punches, reduce friction
and improve the rate of flow of the tablet granulation. Such as
magnesium stearate, polyethylene glycol, corn starch and talc.
5. Colouring and flavouring agents: indigo carmine, sunset yellow, mannitol,
sugar are used.
Dispensing: Raw materials required for the production of a particular
tablet is weighed and distributed into batches.
Sifting: Raw materials are put through sifter or sieve to separate fine
from coarse particles.
Milling: This is done to reduce granule size. Size can affect the
dissolution rate and hardness of the tablet.
Granulation: two types of granulation:
1. Dry granulation- Mixing of raw materials to form granules without
using the liquid solution. Particles may be sensitive to moisture and heat.
2. Wet granulation-liquid binders or adhesives are added to the raw
materials while mixing to form granules. The mixture is then dried and
sized and lubricated.
Compression: Tablets are being formed by compressing the granules
using compression machine.
Coating: Sugar coating, enteric coating etc. is done to the compressed
tablets.
Primary packaging: Primary packaging is the material that first envelops the
product and holds it. This usually is the smallest unit of distribution or use and is the
package which is in direct contact with the contents.
Blister, ALU ALU, Aluminium foils, strips
Secondary packaging: Secondary packaging is outside the primary packaging -
perhaps used to group primary packages together.
Placement in cases
Placement in stand
Labelling of jars/tablet bottles/bottles/tubes
Tertiary packaging: Tertiary packaging is used for bulk handling warehouse
storage and transport shipping.
DISPENSING ROOM SIFTING MACHINE
MILLING MACHINE RAPID MIXER GRANULATOR
COMPRSSION MACHINE
Primary packaging
Secondary packaging Tertiary packaging
THANK YOU