Purified Water Testing in Pharmaceuticals

Dec 8, 2011, , No comments
Testing of Water Samples • pH: - 1. Use pH meter previously calibrated using three point calibration method at pH
2. 4.0, pH 7.0 and pH 10.0 using NIST traceable standard buffers.
3. Calibration Frequency: Daily
4. Acceptance Criteria: Variance NMT 0.05
5. Always preserve the electrode in saturated Kcl solution.
6. Rinse clean the electrode with purified water
7. While testing ensure tem…
Read Full

Sampling, Preservation and Storage Procedure of Water Sample

Dec 5, 2011, No comments
Sampling Procedure 1. Collect water samples for microbiological analysis in clean and sterilized nonreactive borosilicate glass or polypropylene bottles.
2. Neutralize the chlorinated water sampled by adding 1% sterile sodium thiosulphate solution.
3. Open the sampling port/tap fully and allow the water to drain for validated time to remove the contamination in the pipeline.
4. Adjust the flow t…
Read Full

Types of Water used in Pharmaceutical Processes

Dec 1, 2011 3 comments
1. Potable Water:Used in early stages of chemical synthesisUsed Early stages of Equipment CleaningSources: Public water supply, wells or combination of > 1 of theseMust meet Requirements of USEPA (40 CFR 141)Seasonal variations in quality may occur and must be considered for treatment before usage.
2. Purified Water:Used as excipients in the manufacturing of pharmaceuticals.Used for Equipment…
Read Full

Dry Granulation Process

Nov 28, 2011 No comments
The dry granulation process is used to form granules without using a liquid solution because the product to be granulated may be sensitive to moisture and heat. Forming granules without moisture requires compacting and densifying the powders. Dry granulation can be conducted on a tablet press using slugging tooling or on a roller compactor commonly referred to as a When a tablet press is used fo…
Read Full

Wet Granulation Process

Nov 11, 2011 No comments
lWet granulation forms by binding the powderstogether with an adhesive, instead of by compaction. bridges are developed between the particles and the tensile strength of bonds increases as the amount of liquid added is increased.

Wet granulation involves the massing of a mix of dry primary powder particlesusing a granulating fluid.The fluid contains a solvent which can be removed by drying, and s…
Read Full

Granulation and Particle-Bonding Mechanism of Granulation

Nov 8, 2011 No comments
What is Granulation? Granulation is the process in which powder particles are made to adhere to form agglomerates called granules.
Why Granulation? To prevent segregation of the constituents of the mix.
To improve the flow properties of the mix.
To change the particle size distribution so as to improve the compressibility and to increase apparent density of the powder.

Reasons for granulation are…
Read Full

Difference Between Water (Moisture) Content and Loss on Drying (LOD)

Nov 3, 2011, 4 comments
A lot of pharma professionals have the confusion regarding the concept of water content (moisture content) and loss on drying. Both have a considerable difference to understand.

Water content is determined by the Karl Fischer titration method and it consists of only water i.e moisture content. The results do not contain other volatile matter except the water.

Loss on drying (LOD) is determined by…
Read Full

Summary of ISO 14644 (ISO Cleanliness Classes)

Oct 20, 2011, No comments
ISO-14644-1 Classification of Air Cleanliness Cleanliness class designations and quantity have changed from FS209E (see table A). Along with the obvious change to metric measure of air volume, ISO 14644-1 adds three additional classes - two cleaner than Class 10 and one dirtier than Class 100,000.

Table A
Airborne Particulate Cleanliness Classes CLASS Number of Particles per Cubic Meter by Microme…
Read Full