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Sep 28, 2014

Mixed Bed Ion Exchanger in Purified Water System


Water is a key element for the pharmaceutical and healthcare industries. Pharmaceutical manufacturers are concerned with producing purified water that meets defined standard quality to minimize any risk to patients' health or interfere with the manufacturing process. Water acts as an important ingredient in many formulations and also as a cleaning agent. This makes the production of highly purified water and pyrogen free for injection to very critical and should meet the international standards. The most commonly and accepted method of purification is the use of mixed bed ion exchanger in the purified water systems for pharmaceuticals.

Sep 21, 2014

Sanitization of RO Membranes in Purified Water System


The main ingredient in most of the pharmaceutical products used by people is water. Given the ever increasing concerns about the ingredients used to make pharmaceutical products, it is important to ensure that the water used is stable and consistent. The Reverse Osmosis (RO) system is at the heart of the process of water purification. It uses semi-permeable polyamide membranes that provide rejections of organic and ionic impurities that exceed 99%. The RO membranes pores are in real sense intersegmental spaces within the polymer molecules. The membranes are large enough to allow permeation of water molecules but not big enough to allow hydrated chemical ions to pass through. Below is a look at how sanitization of membranes in purified water system is done. 
Sep 14, 2014

Calculation for Determination of Weighing Range of Balances


Balances are used to weigh different things as raw material, dispensed material and samples. Sometimes very low quantity is weighed for analysis. An error in the weighed material can cause a big variation in analytical results.
Sep 12, 2014

Understanding the Process of Finding Impurities in Pharmaceutical Analysis


The primary goal of any synthetic process is to create completely pure products, though in reality marginal amount of impurity always has been found to be present in the final product after the complete chemical synthesis and manufacturing process. The presence of the impurities can enhance the level of toxicity and that is why an impurity analysis process has been carried out. Understanding the nature of these impurities is important. The goal of the analysis is to check whether these impurities may bring possible hazards or not. There are some known and unknown impurities in pharmaceutical analysis. The intention of pharmaceutical analysis should be to omit these impurities completely; if not then their intensity should be taken down to a controllable level so that no possible hazards can take place.
Sep 7, 2014

Significant Change in Pharmaceutical Stability Testing


Stability of the pharmaceutical products is determined by storing the product under Accelerated and Long Term Conditions. The product is then analyzed at different time stations for any significant change in physical or chemical condition.
Sep 1, 2014

Shelf Life Estimation of Pharmaceutical Products


All pharmaceutical drugs degrade with the time forming the byproducts. These byproducts may harmful for health of the patients consuming the drug. Shelf life of the pharmaceutical products is the time period for which the product maintains its identity and quality when stored at the conditions defined on the label of the product.
Aug 24, 2014

Sampling and Testing in Exhibit and Process Validation Batches


Sample is a portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to allow all anticipated test procedures to be carried out, including all repetitions and retention samples.
Aug 20, 2014

Forced Degradation Study in Pharmaceutical Stability


Forced degradation is also known as stress testing and drug is degraded forcefully by applying artificial methods. It is a useful tool to predict the stability of any Active Pharmaceutical Ingredient (API) or formulation product. It helps to know about the impurities developed during the storage of drug products in various environmental conditions.
Aug 13, 2014

Planning and Procedure followed During Regulatory Audits


Different types of inspections are conducted by Regulatory Agencies. Following are the various types of inspections conducted periodically by Regulatory Agencies. 
  1. Routine Inspection: Quality System Inspection
  2. Pre-approval Inspection for Pre-market Approval (PMA): Country specific inspections
  3. Follow-up on a warning letter (Violation): Inspector will look for evidence of the company's compliance with a plan of action made in the response to the warning letter.
  4. For-cause Inspection (Investigational): Inspectors have specific directions for the inspection that are not publicly available. 
Aug 7, 2014

Absorption, Distribution, Metabolism and Excretion of Drug


In order to achieve its effect, a drug must first be administered in a suitable dosage form at an appropriate site. It must be absorbed effectively from the site of administration and distributed in the body to reach its site of action. After its action, for the termination of its effect, the drug must be metabolized, and metabolites must be excreted from the body.
Aug 3, 2014

Principle and Working of Fluidized Bed Dryer (FBD)


Fluidized bed dryer (FBD) is well known and widely used equipment in pharmaceutical manufacturing. It is used in granulation process for drying the material to get desired moisture content in the tablet formulation granules.
Jul 28, 2014

Revalidation of Pharmaceutical Processes


Revalidation of any process is an essential part of the validation. It improves the quality of the product and increases the smoothness of the process.
Jul 20, 2014

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.

Jul 13, 2014

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.
Jul 11, 2014

Different Routes of Drug Administration


Routes of administration of a drug is determined by its physical and chemical properties, patient characteristics and the rapidity of response desired. Major routes are oral, parenteral and topical.
Jul 7, 2014

Different Types of Dosage Forms in Pharmaceuticals


A drug is defined as a substance used for diagnosis, prevention and treatment of disease. A dosage form of a drug is a product suited for administration to the patient by various routes for diagnosis or treatment of disease. Suitable dosage forms are needed for protection of the drug from destructive influences of the atmospheric oxygen or moisture, for protection of drug from destruction from gastric acid on oral administration, to mask bitter taste and foul odour, to provide extended drug action through controlled release mechanism etc. Following agents are used with drug for suitable dosage form.
Jul 1, 2014

Requirements for Good Documentation Practice (GDP)


Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document.
Jun 29, 2014

Human Generated Contamination in Cleanroom and its Control


Cleanroom contamination is a major problem in sterile manufacturing and it is difficult to maintain the cleanroom area. People working area are the major source of contamination.
Jun 23, 2014

Importance of Blend Uniformity in Manufacturing Process


Blend uniformity is an important factor in pharmaceutical manufacturing. A poor uniformity of the blend can cause the rejection of the product that can lead to the loss of revenue.
Jun 15, 2014

Optical Activity in Pharmaceutical Analysis


Chiral molecules are able to rotate the plane polarized light and this quality of these molecules is known as optical activity. Optical activity is measured by polarimeter. Polarimeter has a light source, polarizing filter, sampling tube and analyzing lens. Molecules having optical activity are known as optically active molecules.

Jun 8, 2014

Audit Trail Requirements in Pharmaceuticals


The purpose of an audit trail is to make the electronic data secure and traceable. Audit trail is a regulatory requirement in pharmaceutical manufacturing. Audit trail shows in record the name of persons who assessed the computer system with the date and time. It also helps to recover the lost data.
May 26, 2014

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.
May 18, 2014

Taking Care When Buying the Prescription Medicines Online


Buying medicines online through internet can save your time and sometimes money. But you should be careful when ordering the prescription medicines online.
May 14, 2014

Layout for Injection Manufacturing Unit


Area maintenance in sterile manufacturing is a difficult task because most of the areas in sterile manufacturing are of higher grade than the oral manufacturing.