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Pharmaceutical Guidelines

Nov 22, 2015

Buffer Area and Its Maintenance in Sterile Manufacturing Facility

Buffer area is the sterile zones in pharmaceutical manufacturing. Generally compounding area in sterile pharmaceutical preparation facility is known as buffer area. Buffer area is always ISO 7 area (class 10,000) or better air quality.
Nov 15, 2015

Sterile (Cleanroom) Area Qualification

Sterile area qualification and HVAC system qualification are two different things but most of the tests are same because HVAC system is qualified by its performance as quality of the area. Qualification document of the HVAC system and the sterile area should be prepared separately.
Sterile area can be qualified by applying following tests.
Nov 8, 2015

Qualification Procedure for Vial Washing Machine

Sterile pharmaceutical preparations as injections are filled in glass vials. These vials should be cleaned properly before filling. Automatic vial washing machines are used to clean but the process of cleaning of the vials should be validated. The efficiency of these machines is verified by following tests.
Nov 1, 2015

Use of Ultra-Violet Light for Disinfection

UV light is used as a disinfection agent in pharmaceuticals. Short wavelengths of ultraviolet light create harmful effect on microorganisms by destroying their nucleic acids and prevent the growth of the microbial cells.
Oct 25, 2015

Computer System Validation in Pharmaceuticals

Validation is a critical tool to assure the quality of computer system performance. Computer system software validation increases the reliability of systems, resulting in fewer errors and less risk to process and data integrity. Computer system validation also reduces long term system and project costs by minimizing the cost of maintenance and rework.
Oct 18, 2015

Procedure to Develop a HPLC Method

Analytical method development is considered as a critical process in pharmaceuticals. Availability of the different types of columns, operating parameters, mobile phase composition, diluent and pH values make it critical to develop an analytical method. A good analytical method should be simple, used column, mobile phase and buffer should be common. It can be done easily step by step.
Oct 11, 2015

Activated Carbon Filter and Increase in Efficiency for Water System

Activated carbon filter is used to remove chlorine and organic matter from the water. It also removes the color and odor from the water hence the turbidity of water is also removed. It plays an important role in water purification systems where chlorine is added for decontamination. ACF is unable to remove the microbes and hardness.
Oct 4, 2015

Transport Validation for Pharmaceutical Products

In the past, it was not important to validate the transportation of the pharmaceutical products but now it is recommended by all major regulatory agencies. Storage conditions during transit of the pharmaceutical products should be validated because it may affect the product stability.
Sep 27, 2015

Incubation of Petridishes in Inverted Position

Petri dishes were first used by German physician Julius Petri in 1887. He covered one culture plate to another plate to prevent the contamination. Before him the culture plates were covered with the glass bell jars.
Sep 20, 2015

Different Mesh Sizes Used in Pharmaceuticals and Their Conversion

Sieves and screens are widely used in the pharmaceutical manufacturing as well as in the quality control to determine the particle size of the raw materials. Mesh is the most common measurement unit used for the sieves and screens.
Sep 13, 2015

Maintenance of Pharmaceutical Clean Areas: FDA Recommendation

Maintenance of clean area has its importance in sterile manufacturing. Sterility of the sterile products is the most important factor for the product quality and it can be achieved only by the proper maintenance of the manufacturing area.
Sep 6, 2015

Effectiveness and Criteria to Replace the UV Lights

Ultra violet radiation plays a vital role in pharmaceutical industry to control the microbial contamination in various stages including water system. No chemical is required to add in water; hence the procedure is environment friendly and safe. A high dose of UV radiation is required to control the microbes and the process can be reverse in the presence of light. This dose should damage their nucleic acid too enough so that it could not be repaired again by the process of photo-reactivation in the presence of light.

Aug 30, 2015

Reverse Osmosis (RO) System for Water Purification

Reverse osmosis is the best known filtration method and it is widely used in pharmaceutical water systems. This process is used to remove the particles including ions from the water. Reverse osmosis system contain a semi-permeable membrane that allows to pass the water and rejects the contaminants.
Aug 23, 2015

Principle and Working of pH Probes

A pH meter is used to determine the acidity or alkalinity of the solution. pH is the concentration of hydrogen ions in the solution. A solution containing more H+ ions remains acidic while the solution containing more OH- ions remains alkaline. pH value of solutions ranges from 1 to 14.
Aug 16, 2015

Chemical Sanitization of RO Systems and Biofilm Removal

To control microbial growth, RO systems must be chemically sanitized on a regular basis. Prior to sanitation it is important to chemically clean the first-pass RO system. This will help to disrupt any biofilm that protects viable bacteria from contact with the sanitant. It also removes foulants that will react with and chemically deplete the sanitizing agent. 
Aug 9, 2015

Different Storage Conditions in Pharmaceuticals

Different storage conditions are required in pharmaceuticals. In storage area drug substances are stored on different conditions according to their requirements. Some chemicals and solutions in quality control and media in microbiology section are required to store in specific conditions.
Aug 2, 2015

Different Types of Temperature Sensors

Temperature sensors are used in different processes in pharmaceuticals. Different types of temperatures are used in different processes according to their accuracy needs.
There are following three common types of temperature sensors.
Jul 26, 2015

Quality Risk Management in Pharmaceuticals

Any process that can have any type of risk should go through the quality risk management. These risks may impact the quality of the pharmaceutical products. It is a requirement of good manufacturing practices. Quality risk management is an effective tool to maintain and improve the quality of the pharmaceutical products.
Jul 19, 2015

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.
Jul 12, 2015

Importance of Mixing Time in Pharmaceutical Manufacturing

In pharmaceutical manufacturing more than one ingredients are mixed during blending. It always remains in one's mind that what will happened if we increase the mixing time than specified in the batch manufacturing records.
Jul 6, 2015

Technology Transfer in Pharmaceuticals

Technology transfer is the process by which the manufacturing process and analytical method is transferred from one manufacturing unit to another unit or from R&D to manufacturing unit.
Jun 28, 2015

Hold Time Study in Pharmaceutical Manufacturing

Sometimes during manufacturing, the in-process materials need to be hold for a period more than usual. Hold time study during manufacturing is validation of the hold time period of in-process materials. Now hold time study during pharmaceutical manufacturing has more importance because it is now recommended by the World Health Organization (WHO).
Jun 21, 2015

Incubation Conditions for Common Media used for Fungus and Bacteria

It confuses every microbiologist in pharmaceuticals to incubate the common plates for fungal count and bacterial count that which temperature should choose first for best growth of fungus and bacteria both.
Jun 14, 2015

How to plan for a GMP audit in Pharmaceuticals?

GMP audit of any pharmaceutical industry is very critical and important in the terms of its business. Therefore, the preparations of the audit should be done properly before the audit.
Jun 8, 2015

Disinfectant Solutions and Their Mechanism of Action

A lot of disinfectants are used for sanitization and disinfection in pharmaceutical industries. These have different antimicrobial properties based on their mode of action. Disinfectants having different mode of actions are helpful to prevent the development of the resistance in microbes.

May 31, 2015

Detergents Used for Cleaning of Pharmaceutical Equipments

There are different types of detergents such as anionic detergents, cationic detergents, amphoteric detergents, alkaline detergent etc. This nature of the detergent depends upon the nature of the surfactant found in the detergent. These all have their specific use due to their cleaning properties.