Isolators in pharma manufacturing.
What is an Isolator- A decontaminated unit, supplied with Class 100 (ISO 5) or higher air quality, that provides uncompromised, continuous isolation of its interior from the external environment (e.g., surrounding cleanroom air and personnel). There are two major types of isolators:
Closed isolator systems exclude external contamination from the isolator’s interior by accomplishing material transfer via aseptic connection to auxiliary equipment, rather than use of openings to the surrounding environment. Closed systems remain sealed throughout operations.
Open isolator systems are designed to allow for the continuous or semi-continuous ingress and/or egress of materials during operations through one or more openings. Openings are engineered (e.g., using continuous overpressure) to exclude the entry of external contamination into the isolator.
In pharmaceutical industry certain operations in pharma manufacturing or a quality control process , some drugs , some materials are required to be handled very carefully so as to protect them from getting contaminated by microorganisms and particulate matter, or it is required to handle a material separately and carefully if it is highly potent and sensitive to moisture and oxygen , as well as operators are required to be protected from untoward hazardous effects of such drugs or materials on their body, example* are cytotoxic, hormones, and radiopharmaceuticals , such materials are hazardous to surrounding environment and to the operator's health as well.
Such materials are required to be handled in a system or unit which is completely closed and offer complete isolation of such materials or products from surrounding environment as well as from personals processing such materials. Such units which offer these facilities of isolation of such materials from surrounding environment are called as isolators, Isolators are used to handle such materials with ease, Isolators are widely used in processing of such materials by mechanical isolation, isolator systems are available in variety of form size and shape. One can design a manufacturing process line of isolator system where more than one person can work at a time and can carryout an operation, with the help of multiple glove attachments, hence isolator is also called as glove box.
Isolators are widely used for sterile manipulations in aseptic manufacturing of sterile dosage form or an injectable dosage form, Isolators can be supplied with HEPA filtered air and to maintain its sterility in aseptic processing, as well as they can be integrated inert gas purification system and activated charcoal air filtration for handling of materials sensitive to oxygen, and moisture. Processes like weighing, dispensing, and forming a triturate of sensitive material or to compound them in to final product can be accomplished in to an isolator. An antivibration support assembly can be integrated in a isolator to weigh potent drugs accurately in to them.
Isolators are fabricated with stainless steel 316 with surfaces electropolisehed, joints and corners are rounded so as to facilitate easy cleaning and to prevent accumulation of microorganisms or microbial spors, they can be fitted with glass walls for visual observation of process being carried out, Isolators can be fitted with one or more pairs of gloves , so as to facilitate handling of hazardous materials, material containers which are sterile or highly potent or cytotoxic are opened inside a closed isolator system and after the required process or manipulations and then the container is closed again without exposing it to surrounding environment and affecting surrounding environment ,without affecting sterility of material being handled. Isolator systems can be integrated to an oven to facilitate variety of applications of an oven ranging from sterilization to drying.
Also see -->
Isolator and sterile dosage form injectable dosage form manufacturing using isolators
Aspects of aseptic process isolators in sterile dosage form manufacturing <----You should not miss this article
=====================================================================================================
Do you know now this website has become a most popular and most referred website in pharmaceutical industry and in pharmaceutical companies by pharmaceutical manufacturers from all over the world for almost all topics related to FDA guildelines, GMP guidelines for Pharmaceutical Manufacturing (Current Good Manufacturing Practice for Pharmaceutical Manufacturing , c GMP guidelines ),and technical aspects of pharma manufacturing research and development , Pharma Regulatory Affairs and latest news and new drugs developments.
=====================================================================================================
You may also like following articles
What is Therapeutic Index ?
What is Narrow Therapeutic Range Drug?
What is High Efficiency Particulate Air( HEPA ) filter ?
What is a Laminar Air Flow Cabinet.
What is an Isolator in pharmaceutical manufacturing.?
What is 21 CFR Part 11, US FDA compliance and CFR 21 Part 11?
CFR 21 part 11 and its application on computarised systems used in clinical trials US FDA guidelines
What is High-Efficiency Particulate Air HEPA Filter
What is 21 CFR Part 11, US FDA guidelines requirements of FDA compliance and CFR 21 Part 11.
What is a Site Master file of a pharmaceutical company
What is Generic Drug
What is Reference Listed Drug ? ( RLD )
What is Pharmaceutical Equivalents
What is Pharmaceutical Alternatives
What is Therapeutic Equivalents
What are Post Market studies
Why a drug is bound to protein, What is protein binding? What is drug absorption , distribution ?
Do Physical properties contribute to drug activity.
What is drug receptor , How a drug resistance occurs
Mechanism of drug resistance
What is drug interaction
Drug interaction, and its examples
What is first pass metabolism of a drug
What is What is 510(k) Clearances ?
What is 510(k) Clearances,
Premarket Notification for medical devices - PMN or 510(k)
What is a drug interaction
Examples of drug interactions
Antibiotic Definition and classification
Antibiotic Resistance and Antibiotic resistance mechanism
Antioxidants food supplements
Vitamin D Details on FDA cautions on accurate dosage of Vitamin D
What is an antibody? what is monoclonal and polyclonal antibodies?
Terminologies In vaccine Production
Multi stage testing of Virus vaccine production
Testing of vaccines at different stages of production
TESTING FOR ADVENTITIOUS AGENTS CELL PROPERTIES IN VIRAL VACCINE PRODUCTION
Enzyme linked immunosorbent assay ELISA
Raido Immuno assay
http://whoguideline.blogspot.com/2010/04/terminalogy-and-their-explanations.html
Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definitions.
http://whoguideline.blogspot.com/2010/02/pharmaceutical-aseptic-manufacturing.html
Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in
pharmaceutical industry
Pharmaceutical Validation
Types of validations in pharmaceutical manufacturing
Requirements of documents for validation of sterilisation process
How to investigate OOS out of specification results
Determination of Phenol coefficient of a disinfectant
Sterility testing
Clean Room Classification
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Clinical Trials
Requirements of US FDA Inspections of Clinical Investigators of Clinical Trials
PROCEDURE OF AN INSPECTIONS OF CLINICAL TRIAL INVESTIGATOR BY US FDA HOW ARE CLINICAL INVESTIGATOR INSPECTIONS CONDUCTED?
US FDA INSPECTION OF CLINICAL INVESTIGATORS OUT OF UNITED STATES OF AMERICA
REPORTS AFTER AN INSPECTION OF A INVESTIGAOTR OF CLINICAL TRIALS
Controlling Pyrogens in injectable dosage forms
Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation
Injectable Dosage Form Asepict Techniques Sterile dosage form manufacturing imprtant aseptic techniques
New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
Abbreviated New Drug Application (ANDA) What is ANDA , detailed information about ANDA preparation and submission to US FDA
How to make Investigational New Drug (IND) Application to US FDA
Drug applications submission to us fda Over the counter Drugs OTC drugs
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Electronic record in pharmaceutical manufacturing industry
Good manufacturing practice in pharmaceutical industry
Pharmaceutical industry pharmaceutical companies and FDA latest updates
Here is an interesting article on world wide pharmaceutical industry and making a carrier in one of pharmaceutical companies article on Pharmaceutical Industry pharmaceutical industry
Find a Job in Pharmaceutical Company -->JOBS IN PHARMA INDUSTRY<---
To Find Pharmaceutical jobs and make a Pharmaceutical careers see here pharmaceutical companies
Here are some interesting articles on Quality assurance systems for pharmaceutical company
Quality assurance in pharma industry
Quality by design concept for pharmaceutical industry
Quality by design concept in pharmaceutical industryan explanation
Useful Books For Pharmaceutical Manufacturers and Pharmaceutical Professionals
What is Therapeutic Index ?
What is Narrow Therapeutic Range Drug?
What is What is a High-Efficiency Particulate Air (HEPA) filter ?
What is 21 CFR Part 11, US FDA compliance and CFR 21 Part 11.
This website is written by experts in Pharmaceutical Industry Manufacturing Research and Development and Regulatory Affairs Since 2008 and in 2011 Awarded as one of top 10 websites across world in Pharmaceutical Manufacturing Regulatory
USFDA WHO GMP Guidelines Pharmaceutical Regulations Information about Pharma Quality Managment System Validations Process Validation Cleaning Validation Equipment Qualification Equipment Process Validation Computer System Validation Sterile Product Manufacturing Guidelines Media fill guideline Aseptic Techniques in Sterile dosage form Clean Room Clean Room Classification Guidelines on Area Qualification HVAC AHU HEPA Filter HEPA Filter integrity testing and leak test
Subscribe to:
Post Comments (Atom)
Pharma Guidelines Most Read
-
Clean Room Classification aspects of cleanroom requirements in aseptic Process in manufacturing of sterile dosage form. Classification o...
-
Clean Room classification Pharmaceutical Manufacturing Area Classification particle count What is a clean room in Pharmaceutical Manufactu...
-
Definitions and Descriptions of process. Type A cleaning: In a continuous production runs, when the cleaning is done in between the comple...
-
Abbreviated New Drug Application (ANDA) What is an Abbreviated New Drug Application (ANDA)? Abbreviated New Drug Application is also kno...
-
WHO GMP Training Questions and Answers Section for pharmaceutical manufacturing units :-Quality Management In this post i am giving some qu...
-
Lyophilisation Freez Drying : When we think about drying process in pharmaceutical manufacturing process, we think of application of he...
-
Pharmaceutical validation In pharmaceutical manufacturing industry Pharma Validation regulatory requirements. Validation in Pharma Indus...
-
HEPA filter w hat is a High-Efficiency Particulate Air (HEPA) filter, ULPA filters? How HEPA filters work, its efficacy test and test for ...
-
In earlier article we have discussed in details about what is therapeutic index and what is meant by narrow therapeutic index drug . Her...
-
What is a Laminar Air Flow Cabinet. Laminar air flow cabinets can provide a clean room environment of class 100 and below, which is atta...
.
-
Clean Room Classification aspects of cleanroom requirements in aseptic Process in manufacturing of sterile dosage form. Classification o...
-
Pharmaceutical validation In pharmaceutical manufacturing industry Pharma Validation regulatory requirements. Validation in Pharma Indus...
-
Corrective and Preventive Action CAPA What is meant by CAPA In Pharma As the title itself suggest CAPA is an important function of qualit...
-
Clean Room classification Pharmaceutical Manufacturing Area Classification particle count What is a clean room in Pharmaceutical Manufactu...
-
Definitions of a drug, Radioactive Drug, Radiopharmaceuticals, Investigational New Drug or Device, Drug product, Drug substance, What is an...
-
Good Manufacturing Practices guidelines its importance in (gmp guidelines) For Pharmaceutical Industry. A drug , medical device can b...
-
In earlier article we have discussed in details about what is therapeutic index and what is meant by narrow therapeutic index drug . Her...
-
Media Fill Run to ensure the sterility Sterile dosage form evaluation of manufacturing process by Process Simulations /media fill run Val...
-
Lyophilisation Freez Drying : When we think about drying process in pharmaceutical manufacturing process, we think of application of he...
-
Ebola virus infection is life threatening almost 95% of infected people lost their life. Only in few instance in USA hospitals like Nebrask...
Readers Visit Number
This website is Authentic Source of Pharmaceutical Guidelines
Pharma Validations Quality Management System USFDA Guidelines WHO GMP Guidelines New Drug Update
This website consist of detail Information about Pharma Guidelines Pharma Regulatory Affairs USFDA Guidelines WHO Guidelines Pharmaceutical Quality Management System Pharma Validations Process Validation Cleaning Validation Equipment Qualification Equipment Process Validation Computer System Validation Sterile Product Manufacturing Guidelines Media fill guideline Aseptic Techniques in Sterile dosage form Clean Room Clean Room Classification Guidelines on Area Qualification HVAC AHU HEPA Filter HEPA Filter integrity testing and leak test
1 comment:
Will you please provide such good knowledge on HVAC system
Post a Comment