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Thursday, February 4, 2010

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definations.

We are providing some terms and their meanings , definations which you all may be aware of , eventhough looking at increasing demand  for them as referance on a single page , we are happy to publish them over this post today.  

We are also going to start a series of training documents for pharmaceutical proffesionals and students who keep intrest in sterile dosage form manufacturing in coming days.

Pharmaceutical Aseptic Manufacturing Process Terms , Terminology and Definations.

Air lock- A small room with interlocked doors, constructed to maintain air pressure control between adjoining rooms (generally with different air cleanliness standards). The intent of an aseptic processing airlock is to preclude ingress of particulate matter and microorganism contamination from a lesser controlled area.

Alert Level- An established microbial or airborne particle level giving early warning of potential drift from normal operating conditions and triggers appropriate scrutiny and follow-up to address the potential problem. Alert levels are always lower than action levels.

Action Level- An established microbial or airborne particle level that, when exceeded, should trigger appropriate investigation and corrective action based on the investigation.

Aseptic Manufacturing Area- The classified part of a facility that includes the aseptic processing room and ancillary cleanrooms. For purposes of this document, this term is synonymous with “aseptic processing facility” as used in the segregated segment context.

Aseptic Processing Facility- A building, or segregated segment of it, containing cleanrooms in which air supply, materials, and equipment are regulated to control microbial and particle contamination.

Aseptic Processing Room- A room in which one or more aseptic activities or processes is performed.

Asepsis- A state of control attained by using an aseptic work area and performing activities in a manner that precludes microbiological contamination of the exposed sterile product.

Bioburden- The total number of microorganisms associated with a specific item prior to sterilization.

Barrier- A physical partition that affords aseptic processing area (ISO 5) protection by partially separating it from the surrounding area.

Biological Indicator (BI)- A population of microorganisms inoculated onto a suitable medium (e.g., solution, container or closure) and placed within appropriate sterilizer load locations to determine the sterilization cycle efficacy of a physical or chemical process. The challenge microorganism is selected based upon its resistance to the given process. Incoming lot D-value and microbiological count define the quality of the BI.

Clean Area- An area with defined particle and microbiological cleanliness standards.

Cleanroom- A room designed, maintained, and controlled to prevent particle and microbiological contamination of drug products. Such a room is assigned and reproducibly meets an appropriate air cleanliness classification.

Component- Any ingredient intended for use in the manufacture of a drug product, including those that may not appear in the final drug product.

Colony Forming Unit (CFU)- A microbiological term that describes the formation of a single macroscopic colony after the introduction of one or more microorganisms to microbiological growth media. One colony forming unit is expressed as 1 CFU.

Critical Area - An area designed to maintain sterility of sterile materials. Sterilized product, containers, closures, and equipment may be exposed in critical areas.

Clean Zone- See Clean Area.

Critical surfaces- Surfaces that may come into contact with or directly affect a sterilized product or its containers or closures. Critical surfaces are rendered sterile prior to the start of the manufacturing operation, and sterility is maintained throughout processing.

Decontamination- A process that eliminates viable bioburden via use of sporicidal chemical agents.

Disinfection- Process by which surface bioburden is reduced to a safe level or eliminated. Some disinfection agents are effective only against vegetative microbes, while others possess additional capability to effectively kill bacterial and fungal spores.

Depyrogenation- A process used to destroy or remove pyrogens (e.g., endotoxin).

D value- The time (in minutes) of exposure at a given temperature that causes a one-log or 90 percent reduction in the population of a specific microorganism.

Dynamic- Conditions relating to clean area classification under conditions of normal production.

Endotoxin- A pyrogenic product (e.g., lipopolysaccharide) present in the bacterial cell wall. Endotoxin can lead to reactions in patients receiving injections ranging from fever to death.

Gowning Qualification- A program that establishes, both initially and on a periodic basis, the capability of an individual to don the complete sterile gown in an aseptic manner.

HEPA filter- High efficiency particulate air filter with minimum 0.3 μm particle retaining efficiency of 99.97 percent.

HVAC- Heating, ventilation, and air conditioning.

Intervention- An aseptic manipulation or activity that occurs at the critical area.

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 isolator.

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.

Laminar flow- An airflow moving in a single direction and in parallel layers at constant velocity from the beginning to the end of a straight line vector.

Operator- Any individual participating in the aseptic processing operation, including line set-up, filler, maintenance, or other personnel associated with aseptic line activities.

Overkill sterilization process- A process that is sufficient to provide at least a 12 log reduction of microorganisms having a minimum D value of 1 minute.

Pyrogen- A substance that induces a febrile reaction in a patient.

Sterile Product- For purposes of this guidance, sterile product refers to one or more of the elements exposed to aseptic conditions and ultimately making up the sterile finished drug product. These elements include the containers, closures, and components of the finished drug product.

Sterilizing grade filter- A filter that, when appropriately validated, will remove all microorganisms from a fluid stream, producing a sterile effluent.

Quality Control Unit- An organizational element with authority and responsibility as defined by 211.22.

Unidirectional flow- An airflow moving in a single direction, in a robust and uniform manner, and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area.

Terminal sterilization- The application of a lethal agent to sealed, finished drug products for the purpose of achieving a predetermined sterility assurance level (SAL) of usually less than 10-6 (i.e., a probability of a nonsterile unit of greater than one in a million).

ULPA filter- Ultra-low penetration air filter with minimum 0.3 μm particle retaining efficiency of 99.999 percent.

Validation- Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.

Pharmaceuticals:-
Pharmaceuticals are substances which contain one or more pharmacologicaly , theraputicaly , active substances, derived from chemical,minarel ,plant ,microbial or animal origin, which exihibt its theraputic, pharmacological,chemical activity when applied or administered to human or animal. They are be used to treat human or animal diseases and disease conditions ,or symptoms.

Good Manufacturing Practice (GMP):
Practice or methods adapted during and before the manufacturing of pharmaceuticals or drug substances to ensure that the pharmaceutical or drug substance manufactured meets highest purity quality standards , methods adapted are mostly pertaining to Personal hygiene , and environmental cleanness , and are to eliminate microbial or particulate contamination or cross contamination.

Current Good Manufacturing Practice (CGMP):-
Any novel, or upgraded methods or systems,operations,with respect to personal hygine, machinery or tools , premises or envirinment and its control which assures better results with respect pharmaceutical good manufacturing parctices in pharma.
That means CGMP is never a constant or a stable rather it is continuous phenomenon of improvement.
Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs in pharma and good manufacturing practice in pharmaceutical industry
Also see Pharma Process Validation

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

Controlling Pyrogens in injectable dosage forms

Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation

New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA

Abbreviated New Drug Application (ANDA) What is ANDA , detaied 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

We encourage you to signe up to this website to get automated delivery of articles in to your email inbox , when ever we publish articles over this website related to pharmaceutical manufacturing , pharmaceutical validations , pharmaceutical quality assurance , Pharmaceutical good manufacturing practices, gmp guidelines cgmp , pharmaceutical regulatory affairs , and compliances related articles

21 cfr Part 11

What is High-Efficiency Particulate Air  HEPA Filter

What is 21 CFR Part 11, US FDA guidelines requirements of FDA compliance cgmp guidelines and CFR 21 Part 11.

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