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Apr 18, 2014

Sampling Plan SQRT n+1 (√n+1) for Pharmaceuticals


Quality of pharmaceutical products majorly depends upon the sampling of the excipents and the active pharmaceutical ingredients. Proper sampling can give us confidence in our analysis. In other words we can say – sampling is a starting process but is has its importance.
Apr 13, 2014

Pass boxes in Classified Areas


Pass box is used to transfer the material from lower cleanliness area to higher cleanliness area or vice-versa in classified area and also known as hatch. Pass box works as a barrier between two cleanliness level areas.
Apr 6, 2014

Temperature and Humidity Validation/Mapping in Storage Area


Temperature and humidity are important factors in the stability of the pharmaceutical ingredients. Temperature sensitive materials can degrade at higher temperature therefore it important to validate the storage area for temperature.
Apr 3, 2014

Types and Requirement of Airlocks in Controlled Areas


Airlock helps to protect the classified area from the contamination that may occur during the entry and exit of personnel and material.
Mar 30, 2014

Cleaning Method Validation Protocol for Pharmaceutical Equipments


Objective:
The purpose of the study is to validate analytical method for determination of traces of   API contents in Swab & Rinse samples and to establish documented evidence and provide the procedure for the same.
Mar 23, 2014

Analytical Method Development Process for New Products


1.0  Objective:
The purpose of the study is to develop analytical method for determination of Assay / Related Substances of new product by HPLC or UV-Vis Spectrophotometer as applicable.
Mar 19, 2014

Why Dissolution Test Apparatus Calibration with Salicylic Acid Tablets was Stopped?


Prednisone and Salicylic acid tablets USP were used for the calibration of dissolution test apparatus. Prednisone tablets were disintegration type and Salicylic acid tablets were non-disintegration type.
Mar 10, 2014

How to Know the Generic Equivalents for Branded Medicines?


Branded medicines are very costly due to the additional cost for the brand promotion. There are a lot of generic alternates for these costly branded medicines. This can help to save money for the same medicines.
Mar 2, 2014

Why Companies are Selling Same Drug in Different Prices?


There is a big difference in the prices of the pharmaceutical products in India. The products having same drugs with same label claim are being sold in different prices. Sometimes this difference increases the prices twice, thrice or even ten folds.
Feb 23, 2014

Tips to Develop Equipment Cleaning Procedure


A well developed cleaning method is a primary requirement of the cleaning validation. Cleaning procedure should be developed before starting the cleaning validation. Following things should be considered during development of good cleaning procedure.
Feb 9, 2014

Validation of Pure Steam


Pure steam is used in various operations in pharmaceuticals but its use in sterilization is very common in pharmaceutical sterile manufacturing.
Feb 3, 2014

Design of a Sterile Facility in Pharmaceuticals


Efficiency and the maintenance of the sterile area directly depend upon the design of the sterile facility. Good design can save the area maintenance cost and quality of the area.
Jan 26, 2014

Is Fungal Count Acceptable in Pharmaceutical Classified Area?


Classified area is monitored for viable and non-viable particles in pharmaceutical manufacturing. Fungus and bacteria both are found in the environment. Both are determined by the air sampling using the growth medium by settle plate and active air sampling methods.
Jan 19, 2014

Dead Leg and its Limit in Water Systems


Water system in pharmaceuticals may the source of contamination for the manufactured products. It is necessary to prevent the water system from the microbial contamination.
Jan 18, 2014

Microbial Analysis of Purified Water and Water of Injection


Water is used in verious processes in pharmaceutical manufacturing. Microbial contamination in water may cause contamination in pharmaceutical products. It is necessory to analyse the Purified Water and Water for Injection (WFI) for microbial contamination.
Jan 15, 2014

Importance and Determination of F0 Value in Sterilization


Generally sterilization is done at 121 °C and it is a standard temperature for sterilization. It we want to sterilize the material at the temperature other than 121 °C then we must change the time of sterilization.


Jan 12, 2014

Determination of Z-Value for Biological Indicators


Z value is the temperature required to increase the thermal destruction by one log. In simple words we can say the temperature required to increase the death rate or D value of the organisms by 10 times.
Jan 6, 2014

Color Codes for the Gas Cylinders in Pharmaceuticals


Gas cylinders are widely used in pharmaceutical industries. It is important to know the color codes of the same because most of the gas cylinders don’t have any written information about their contents. Color codes are given for safety purpose and to prevent mix-ups in handling.
Dec 29, 2013

Mean Kinetic Temperature (MKT) in Stability Studies


Mean Kinetic Temperature is a useful tool used in pharmaceutical stability studies. It helps to calculate the degradation of stability sample.
Dec 23, 2013

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing


Both of these techniques are used to manufacture sterile pharmaceutical products as parenteral (LVP & SVP), infusions, ophthalmic and inhalation products. These are automated techniques to prepare sterile products.
Dec 19, 2013

Log Reduction (D Value) and Sterility Assurance Level (SAL) in Sterilization


Sterilization of pharmaceutical articles is affected by a lot of factors as temperature, population of microbes, quantity of material, sterilization exposure time etc.
Dec 15, 2013

Relative Response Factor (RRF) and its Calculation in HPLC Analysis


During the manufacturing process of active pharmaceutical ingredients some unwanted substance are produced those are known as impurities. Some impurities are raised due to the degradation of actual drug.
Dec 8, 2013

Theoretical Plates and their Determination in HPLC Analysis


Theoretical plates are known as a measuring tool of HPLC column efficiency. Any chromatography column doesn't have any physical plate but it is a result of mathematical calculation.

Nov 29, 2013

Recovery Factor and its Determination in Cleaning Validation


It is necessary to use recovery factor for accurate results in cleaning validation of pharmaceutical manufacturing equipments. Recovery factor is the recovery of swabbed material from the equipment to the solution.