Prospective validation includes those considerations that should be made before an entirely new product is introduced by a firm or when there is a change in the manufacturing process which may affect the product's characteristics, such as uniformity and identity. The following are considered as key elements of prospective validation.
1. Equipment and ProcessThe equipment and process(es) shoul…
Purified Water Testing in Pharmaceuticals
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…
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…
Sampling, Preservation and Storage Procedure of Water Sample
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…
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…
Types of Water used in Pharmaceutical Processes
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…
2. Purified Water:Used as excipients in the manufacturing of pharmaceuticals.Used for Equipment…
Dry Granulation Process
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…
Wet Granulation Process
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…
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…
