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Pharmaceutical Guidelines


May 22, 2016

Role and Calculation of Air Changes per Hour in Clean Room Area


Air changes in pharmaceutical clean room play an important role in maintenance of HVAC clean room quality. Air changes per hour are the number of total replacements of any room’s air in one hour.

May 15, 2016

Validation of Fumigation in Cleanroom Area


Fumigation is the process to disinfect the sterile manufacturing and microbiology testing area. Generally fumigation is not required when AHU runs continuously but when the microbial load increases in the controlled area it is controlled and minimized by fumigation of the area.
May 9, 2016

Importance and Maintenance of Pressure Differential in Manufacturing Area


Pressure differential is difference between atmospheric pressure between production area and its surroundings. It is measured in pascal using magnehelic pressure gauge.
May 2, 2016

Terminal Sterilization of Sterile Pharmaceutical Preparations


Sterile pharmaceutical products, large volume parenterals and small volume parenterals are sterilized after the packing of the final products is known as terminal sterilization. Process is important to assure the sterility of the product.
Apr 25, 2016

Requirement of Alarm System in Critical Equipments


The general function of an alarm is to warn about any critical condition as life threatening danger or any critical environmental condition like building fire alarm etc. But in pharmaceutical manufacturing facility the requirement of audible alarm in critical equipments has its great importance because the change in temperature can affect the pharmaceutical product quality or it can alter the analysis results.
Apr 17, 2016

How to Write a Validation Protocol?


A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and approval.
Apr 10, 2016

How Effectively Execute a Validation Protocol?


Proper execution of protocol is an important part of the validation process. Execution of validation protocol affects the validation results. There should be minimum deviations during the validation process.
Apr 3, 2016

GMP for Sterile Pharmaceutical Manufacturing


Maintenance of sterile area is a critical task because air as well as the personnel working in the sterile classified area are the main source of the contamination. Following are the some good manufacturing practice points those shall help in maintenance of sterile area.
Mar 28, 2016

New Changes in ISO 14644-1:Classification of Air Cleanliness


ISO 14644 Part 1 is a useful guideline to maintain the good manufacturing practices in sterile pharmaceutical manufacturing as well as the oral dosage forms. This document provides the standards for the clean room classification. Revision of the guidance was started since 2007 and its drafts are already published in 2011, 2012, 2014 and 2015 but none was finalized and 1999 version was applicable and expecting a new version.
Mar 13, 2016

Depyrogenation in Injection Manufacturing


Depyrogenation is the removal of pyrogen (endotoxins) from the pharmaceutical materials or equipments. Endotoxins are the lipopolysaccharides found in the cell walls of the gram negative bacteria. Pyrogen causes fever when enter in bloodstream.
Mar 6, 2016

Containers for Pharmaceutical Packaging


Plastics in packaging have proved to be useful for the ease with which they are formed, high quality and the freedom to design. For pharmaceutical products they are primarily made of polymers one of them being polyethylene.
Feb 28, 2016

Working and Principle of Tablet Compression Machine


Tablets are being formed by compressing the granules using the compression machines. Different innovations to tablet compression machines are being done to improve the production rates and now it is possible to produce more than 500,000 tablets per hour. A tablet formation takes place by the combined pressing action of two punches and a die.
Feb 21, 2016

Calculation for Capacity of Tablet Coating Machine


Quantity of tablets used for coating in coating pan plays great role in getting good coating results. Capacity of the coating machine pan should be calculated to get uniform coating. Inadequate quantity of tablets used for coating in pan may cause different coating problems.
Feb 14, 2016

Sanitation of Cleanroom Area in Pharmaceutical Manufacturing


It is important to maintain and clean the sterile pharmaceutical manufacturing clean room area periodically. Area should be clean after a defined period as per standard operating procedure.
Jan 31, 2016

Different Types of HPLC Detectors


HPLC detectors are used in the detection of the solute present in the eluent coming from the HPLC column. They are capable of determining the identity and concentration of eluting compounds in the mobile phase. There are specific detectors which respond to a specific compound and their response is not dependent of mobile phase composition.
Jan 27, 2016

Working and Principle of Tablet Coating Machine


A tablet coating machine is an equipment that coats the external surface of a tablet using a thin film of coating material. Working principle of tablet coating machine is relatively simple where application of coating material is done on a moving bed of tablets and removing rapidly the solvent using a current of hot air.