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May 18, 2015

Preparation of Batch Manufacturing Record (BMR)


Batch manufacturing record is a written document of the batch that is prepared during the pharmaceutical manufacturing process. It contains actual data of the batch manufacturing and whole manufacturing process step by step.
May 13, 2015

Risk of TSE and BSE in Pharmaceutical Products


Pharmaceutical products having raw materials derived from the animal source have risk of Transmissible Spongiform Encephalopathy (TSE). This disease can transmit in human through pharmaceutical dosage forms from the cattle infected with the Bovine Spongiform Encephalopathy (BSE).
May 5, 2015

Poly Alpha Olefin (PAO) and Its Use in Pharmaceuticals


Poly Alpha Olefin (PAO) is used for HVAC qualification in pharmaceuticals. PAO is used as a replacement of the DOP (Dioctyl Phthalate) that was used for this purpose from a long time.

Apr 26, 2015

Pharmaceutical Contamination and Its Control


Introduction of undesired dust or dirt into or on to during manufacturing, packing and transportation is called as contamination and contaminant is the unwanted element being introduced in the system. It is any substance which has an adverse effect on the product or process.

Apr 19, 2015

Fluidized Bed Dryers and Their Filter Bags


Drying in pharmaceutical manufacturing is the removal of water and other liquid solvents from the granules or other materials by heat and a current of air. Fluidized bed dryer is used to dry the granules in pharmaceuticals
Apr 12, 2015

Microbial Resistance against Disinfectants used for Cleaning


Resistance in microbes against the disinfectants used for cleaning is a serious issue in pharmaceuticals but in most of the pharmaceutical manufacturing units it is ignored. Continuous use of same disinfectants may lead to the development of resistance in the microbes.
Apr 6, 2015

‘5 Why’ Tool for Root Cause Analysis in Pharmaceuticals


Root cause analysis is done to determine the main cause of the error or problem caused during the process. Root cause for the out of specification, deviations during manufacturing and market complaints must be determined. Different methods are used for root cause analysis in pharmaceuticals.
Mar 29, 2015

Checks Before and After Installation of HVAC System


HVAC system provides a safe and controlled environment for pharmaceutical manufacturing because most of the pharmaceutical drugs are temperature and humidity sensitive. It also helps to maintain the classified area by controlling the dust particles and microbial load.

Mar 23, 2015

Cellulose Membrane Filters Used in Pharmaceuticals


Membrane filters are thin polymer films those have many microscopic pores. These filters have different pores sizes and used for different purposes accordingly. Membrane filters are used in various pharmaceutical activities. Cellulose filters are most commonly used filters in microbial analysis and reverse osmosis water systems. Most of the cellulose filters are hydrophobic in nature.
Mar 15, 2015

Preservatives and Their Concentrations used in Liquid Preparations


Pharmaceutical preparations have many ingredients those promote the microbial growth. Due to this, these non-sterile products are susceptible to the microbial growth. To prevent this microbial growth, it is required to add some antimicrobial compounds known as preservatives. These preservative does not have any harmful effect on patients consuming the products.
Mar 8, 2015

Binders and Their Concentration in Tablet Manufacturing


Binder is a chemical substance with adhesive property. They bind the excipients and drug together to provide them mechanical strength. They help to form intergranular bonds. The binder may fuse together locally and form binder bridges between granule surfaces which cohere the granules to each other. Such bridges may be the result of a softening or melting of binder layers during compression phase.
Feb 23, 2015

Lubricants and Their Concentration in Pharmaceutical Manufacturing


Lubricants are agents added in small quantities to tablet and capsule formulations to reduce the friction and improve certain processing characteristics.
Feb 15, 2015

Protection of Light Sensitive Pharmaceutical Products


A lot of pharmaceutical products are light sensitive those degrade when directly exposed to the light. Some impurities may develop during this degradation and product may fail during the quality control analysis. These impurities may harm the patient’s health.
Feb 8, 2015

Different Types of Stainless Steels Used in Pharmaceuticals


There are different grades of stainless steels according the composition like 302, 304, 304L, 316, 316L, 410, 430, 440 etc. but all are not used in pharmaceutical. Pharmaceutical equipment are made with the material that should not react with the active material or excipients used in pharmaceutical manufacturing.
Feb 1, 2015

FDA’s Data Integrity Issues during Inspection of Indian Facilities


Maintenance of original raw data is a prime responsibility of all pharmaceutical manufacturing units. Data integrity is to maintain the data securely so that only authorized person can edit or delete and change log must be created for all users. FDA issued seven warning letters related to data integrity in 2014.
Jan 25, 2015

How to Write a Factory Acceptance Test (FAT) Protocol?


Factory Acceptance Test (FAT) is done at the equipment manufacturing site of vendor before the shipping. A proper FAT can help to minimize the problems occur during the installation of the equipment at the site. A FAT protocol can be written as follows.
Jan 18, 2015

Removal of the Pathogenic Bacteria from Water Systems


Pathogens are the microorganisms which are capable the cause disease. All of these microorganisms are harmful for human. Those can survive into the purified water as well as the water for injection. The pathogenic bacteria found in water system are E.coli, Salmonella and Pseudomanas. Generally these are attached in the filtration membranes of water system such as Reverse Osmosis membranes and Ultra-filtration membranes or sometimes a biofilm can be formed in pipelines of water system.
Jan 11, 2015

Preparation of User Requirement Specification (URS) of Equipments


User Requirement Specification (URS) is a list of all requirements of buyer regarding the equipment to be purchased. URS is prepared by the equipment user department. It is sent to equipment manufacturer to make it as desired criteria. Following points should be included in a pharmaceutical URS.
Jan 4, 2015

NOEL and MACO Calculations in Cleaning Validation


NOEL is “No Observed Effect Level” of any pharmaceutical drug. It is determined to calculate the MACO (Maximum Allowable Carry Over) in cleaning validation. NOEL is the amount of drug in mg that does not have any effect on the human health.
Dec 28, 2014

It is Better to Handle the Microbial Cultures in Separate Room


Separate laminar air flow unit in separate room for handling of microbial cultures is a new trend in pharmaceuticals now-a-days. Before some time all microbiological activities were done under same laminar airflow bench including positive cultures, sub-culturing, sample preparation and analysis. But now it is changing to have separate area for culture handling and sample analysis.
Dec 22, 2014

Procedure for Investigation of Media Fill Test Failure


Media fill test assures the sterility of the sterile manufacturing process. When any media fill test fails, it shows the contamination in the manufacturing system. This failure must be investigated.
Dec 15, 2014

How is It Important to Identify the Environmental Isolates?


There are a lot of microorganisms found the air. Mostly microorganisms found in air are bacteria. These are determined by the air sampling methods. Growth of these microbes on nutrient media helps to identify them.

Dec 8, 2014

How to Remove Residual Chlorine before Microbial Analysis?


Raw water is chlorinated by adding sodium hypochlorite (NaOCl) to make its concentration 2-4 ppm. Chlorination of water is done to remove the microbial load from the water. It helps the water system to produce the purified water of specified microbial quality.
Dec 1, 2014

Lubricants Used in Pharmaceutical Manufacturing Equipments


Lubricants are used to minimize the faction between the moving surfaces of the machines. Fraction may cause the heating of the moving parts. It also helps to minimize the load on the machine and rust. Generally lubricants are prepared with organic and synthetic compound those are not permitted in pharmaceuticals.
Nov 23, 2014

Drift and Its Importance in Analytical Balances


In the pharmaceutical industry and bioscience research field, many laboratories make use of analytical balances. The analytical balances used in the bioscience research and pharmaceutical industry are very sensitive. These balances can be heavily affected by the way the measuring personnel handle them and by the environment in which they are installed. The environment in the pharmaceutical laboratory needs to be assessed by running assessment tests. Based on the results of these assessments should be proposed concrete measures for improving the lab environment.


 

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