what is aseptic processing in pharmaceuticals

The Aseptic Manufacturing Process

• Bulk Drug Substance Arrival. The bulk drug substance, or BDS, is delivered to the manufacturing facility and transferred to storage until it is needed.
• Pooling and Formulation. ...
• Component Preparation. ...
• Sterile Filtration. ...
• Sampling and Testing. ...
• Aseptic Filling. ...
• Lyophilization. ...
• Inspection. ...
• Shipping. ...

Full Answer

What makes aseptic different from hot-fill processing?

Aseptic is a desirable alternative to hot-fill or retort processing because it doesn't expose products to extended periods of high thermal temperatures, which can lead to vitamin, color, taste, and texture degradation. The aseptic process ultimately ensures a better quality product that can still maintain shelf-stable distribution.

What are the basics of sterile processing?

Policies and procedures pertain to:

• Decontaminating, terminally sterilizing, and cleaning all reusable items; disposing of disposable items.
• Packaging and labeling of items.
• Loading and unloading the sterilizer.
• Operating the sterilizer.
• Monitoring and maintaining records of each cycle.
• Adhering to safety precautions and preventive maintenance protocol.
• Storing of sterile items.

More items...

What are aseptic technique procedures in a pharmacy?

Aseptic Technique A set of specific work practices and procedures performed under carefully controlled conditions with the goal of minimizing the introduction of contamination.1 1Kastango ES. Spread the Word: Aseptic Technique Prevents Infection. Pharmacy Purchasing and Products Magazine. April 2009.

How to use "aseptic" in a sentence?

aseptic technique in a sentence

• Biopharmaceutical drug manufacturers widely use aseptic sampling devices to enhance aseptic technique.
• In either case, strict aseptic technique must be maintained during insertion.
• Maintain aseptic technique while handling Cleviprex.
• Aseptic techniques were common in Europe and Asia before they were introduced in the United States in the 1980s.

technique.html More items...

What is meant by aseptic processing?

Aseptic processing can be defined as the processing and packaging of a commercially sterile product into sterilised containers followed by hermetic sealing with a sterilised closure in a manner that prevents viable microbiological recontamination of the sterile product (Betta et al., 2011).

What is aseptic technique in pharmaceutical industry?

To protect patients from harmful bacteria and other pathogens during medical procedures, healthcare providers use aseptic technique. Aseptic technique means using practices and procedures to prevent contamination from pathogens. It involves applying the strictest rules to minimize the risk of infection.

What are the characteristics of aseptic processing?

Aseptic processing equipment sterilization procedures often use steam or hot water under pressure. Packaging equipment and packaging materials are sterilized with various medium or combination of mediums (i.e., saturated steam, superheated steam, hydrogen peroxide and heat and other treatments).

What is the difference between aseptic and sterile?

Although aseptic and sterile both basically mean “germ-free,” sterile is more likely to describe medical environments, products, and instruments that have been cleaned (sterilized). Aseptic is more likely to describe techniques that keep an environment in its sterile state.

What are examples of aseptic techniques?

Aseptic preparation may involve: disinfecting a patient's skin using antiseptic wipes. sterilizing equipment and instruments before a procedure. keeping sterilized instruments inside plastic wrappers to prevent contamination before use.

What are the 13 principles of sterile technique?

Terms in this set (13)Only sterile items are used within the sterile field.Sterile persons are gowned and gloved; gowns are sterile from table to chest level in front including sleeves to 2" above the elbow.Tables are sterile only at table level.Sterile persons touch only sterile items or areas.More items...

What are the requirements needed in aseptic?

Equipment is aseptic if it can be cleaned and sterilized and if it prevents the entry of microorganisms from the external environment to food contact surfaces. In other words aseptic equipment, to the point of filling, must ensure that there is no addition of microorganisms to the food product.

Why is aseptic technique used?

In the microbiology lab we use aseptic technique to: Prevent contamination of the specific microorganism we are working with. Prevent contamination of the room and personnel with the microorganism we are working with.

What are the main factors for the aseptic culture?

The elements of aseptic technique are a sterile work area, good personal hygiene, sterile reagents and media, and sterile handling.

What is the most important aseptic technique?

The most common type of aseptic technique, this is the sterilization process used for things like dialysis or IV insertions. Doctors use handwashing, small aseptic fields, and masks and gloves to keep these small areas free from germs.

What do you mean by aseptic?

aseptic • \ay-SEP-tik\ • adjective. 1 a : preventing infection b : free or freed from pathogenic microorganisms 2 : lacking vitality, emotion, or warmth. Examples: Patients with compromised immune systems must be treated in aseptic environments. "[

Why is aseptic technique important in the laboratory?

Microbiologists use aseptic technique for a variety of procedures such as transferring cultures, inoculating media, isolation of pure cultures, and for performing microbiological tests. Proper aseptic technique prevents contamination of cultures from foreign bacteria inherent in the environment.

What is aseptic technique and why is it important in microbiology?

Aseptic technique commonly maintains pure stock cultures and single spore culture while transferring cultures into fresh media. Appropriate aseptic techniques prevent microbes from unintentionally released into the environment and/or contaminating lab user in the laboratory.

What is aseptic processing?

This requires a special manufacturing process called aseptic processing, or fill-finish manufacturing, which addresses risks through a range of cleaning, sterilization, and isolation practices.

What is aseptic manufacturing?

Aseptic refers to a process that is orchestrated to make a product without microorganisms present at any point from start to finish.

Why is sterile filtration important?

It’s important to use accurately sized filters to reduce hold-up and loss of high-value biologics. Of note, peristaltic pumps (versus piston pumps) have become the standard for many biologics filling processes.

What are the challenges of aseptic processing?

The challenges of aseptic processing. Aseptic processing hinges on technique, detailed procedures, equipment, and controls. It comes with more risks than non-sterile processes. Therefore, it requires more specialization and analysis than some other pharmaceutical processes such as oral solid dosing.

Why is temperature control important in aseptic process?

Temperature control plays an important role in maintaining stability. Risk of loss: There is huge potential for loss of valuable product.

Why is stability important in biopharmaceuticals?

Proteins have limited stability in their liquid state so special care must be taken to preserve a protein’s three-dimensional (3D) structure during the entire aseptic process. Temperature control plays an important role in maintaining stability.

Can aseptics be used for heat sterilization?

Regulatory agencies state that terminal sterilization should be used for any product that can withstand it. Aseptic processing is reserved for any filling operation where the drug cannot withstand the heat cycle of terminal sterilization. Why is this? Advanced aseptic techniques require a higher level of engineering and operation to produce safe products. Instead, it is far simpler and less costly to reduce bioburden along the process and then terminally sterilize with heat. There are many drugs that cannot withstand a heat sterilization step including most biologics, vaccines, and cancer drugs.

What is aseptic processing?

Aseptic processing is defined as “handling of sterile product, containers, and/or devices in a controlled environment, in which the air supply, materials, equipment, and personnel are regulated to maintain sterility” (ISO 13408-1, 2008).

Why is aseptic processing important?

Terminal sterilization is the preferred method; however aseptic processing is sometimes required because certain materials suffer structural or chemical changes. For example, high molecular weight polymers, such as hyaluronate undergo significant molecular weight changes following terminal sterilization. Implant materials expected to deliver a biological activity often lose this property following terminal sterilization ( Khabarov et al., 2014 ). For example, demineralized bone matrix (DBM) is considered to deliver an osteoinductive signal through nascent growth factors copurified with the tissue ( Gruskin et al., 2012 ). Terminal sterilization has been shown to significantly reduce osteoinductive potential of DBM because of degradation of these growth factors ( Glowacki, 2005; Russell and Block, 1999 ). Human cells, tissues, and cellular and tissue-based products (HCT/Ps) that contain living cells are also aseptically processed to preserve the vitality of the tissue.

What is terminal sterilization?

Terminal sterilization. One of two type of processing methods (also aseptic processing) to help eliminate the risk of infection; associated with sterility assurance level (SAL) and is predictive within a measurable range based on the likelihood that one disease-causing germ remains after sterilization.

How was the aseptic system maintained?

Aseptic conditions were maintained by a number of measures such as disinfectants, a steady stream of superheated steam, UV radiation etc. The aseptic enclosure was kept at slight over-pressure to prevent penetration of air from outside.

How were cans sterilized?

The cans and lids were sterilized with steam or a mixture of superheated steam and air. The sterilized food and the sterile cans met in an aseptic enclosure that contained the filling machine and the seamer, closely coupled.

When was the FDA guidelines on sterile drugs produced?

The FDA “Guideline on Sterile Drug Products Produced by Aseptic Processing” (June 1987 ) states:

Can medical devices be sterilized?

Since better process control and patient safety is achieved through terminal sterilization processes, the current regulatory environment requires medical device manufacturers to demonstrate that a product cannot be terminally sterilized before they can convert to an aseptic process. The extent of this demonstration is not well defined. To serve the needs of the industry when a terminal sterilization option is not achievable, there is current activity within the ISO TC198 Working Group 9 on development of a standard for solid medical devices (ISO/Committee Draft 13408-7, Aseptic processing of health care products – Part 7: Aseptic qualification of solid medical devices and combination medical devices ). It is hoped that the creative terminal sterilization options provided in this chapter will permit some biomaterials scientists to avoid this option.

What is aseptic processing?

Aseptic processing and packaging is a sophisticated food preservation method where the food is sterilized or commercially sterilized outside the container and then placed in previously sterilized containers and sealed in an aseptic environment.

What is an aseptic system?

Aseptic systems use ultrahigh-temperature (UHT) sterilization, a fast heating treatment at temperatures higher than pasteurization temperatures. Paper and plastic packaging materials are sterilized, formed, filled, and sealed in a continuous operation at the end of the processing line. Aseptic packaging is also used with metal cans, ...

How to sterilize aseptic packaging?

Packages for aseptic processing can be sterilized by heat treatment (saturated steam, superheated steam, hot air, mixture of hot air and steam), mechanical processes (water/rinsing/flushing, air blasting, brushing, ultrasound), irradiation (ionizing rays, ultraviolet, infrared) or chemical treatments (hydrogen peroxide, ozone, chlorine, peracetic acid, etc). These treatments can be used alone or in combination ( Floros, 1993 ).

What is aseptic technique?

Aseptic technique is a set of principles and practices used by cell culture workers to reduce the presence of unwanted microorganisms or other cell lines in their cultures. Good aseptic technique is essential for successful long-term cell and tissue culture. Here are some useful recommendations to help improve aseptic technique:

Why do aseptic systems require sophisticated instrumentation?

Aseptic systems are quite complex and require sophisticated instrumentation to insure that an adequate process is delivered and that sterility is maintained. These systems require highly trained personnel.

Why is a package hermetically sealed?

The package is hermetically sealed to produce a shelf-stable product that can be stored at ambient conditions. As the food product and package are sterilized separately, a wide variety of package designs and materials can be used for aseptic processing as compared to pasteurization or retorting.

Does aseptic packing have advantages?

Aseptic processing and packing has limitations and it does not offer advantages with all products. Some frequently cited limitations are

WHAT IS ASEPTIC MANUFACTURING?

Aseptic Manufacturing and Sterile Fill-Finish is a process where a drug product, container, and closure are sterilized. Next, the sterilized products are moved to a cleanroom to combine the products. Self-contained equipment is typically used during this process.

What are some examples of aseptics?

Some examples of vials, pre-filled syringes, and cartridges used during the aseptic manufacturing process include: Borosilicate Glass for its excellent barrier properties, chemical resistance, regulatory acceptance, and a broad range of applications served. Polymeric materials such as cyclic olefin copolymer (COC).

Why is injectable drug delivery terminally sterilized?

Terminal Sterilization. Because injectable drug delivery bypasses the body’s natural filters that protect against bacteria and viruses, this delivery means requires drugs to be terminally sterilized or produced using an aseptic process.

When looking to produce an aseptic or sterile fill-finish parenteral product, it is crucial to answer?

When looking to produce an Aseptic or Sterile Fill-Finish parenteral product, it is crucial to follow the cGMP guidelines provided by the FDA. Whether you are producing the drug yourself, or more likely, partnering with a cGMP Certified CDMO - it is important to be aware of the guidelines.

What is parenteral drug administration?

INTRODUCTION TO PARENTERAL DRUGS. Parenteral drug administration is a non-oral drug or substance administered to your body internally. While there are many methods of routes, parenteral administration is done through injection (needle) bypassing the skin and mucous membranes.

Why is it important to make sure the container, (vial or syringe) it comes in provides?

Therefore, it is important to make sure the container, (vial or syringe) it comes in provides excellent stability to support the pharmaceutical efficacy of these often highly expensive drugs. These products use an Aseptic Manufacturing / Sterile Fill-Finish methodology to improve the bioavailability of the drug.

What is ISPE in pharmaceuticals?

ISPE is the global industry leader in connecting pharmaceutical knowledge to deliver manufacturing and supply chain innovation, operational excellence and regulatory insights to enhance industry efforts to develop, manufacture and reliably deliver quality medicines to patients.

Overview

Aseptic processing is a processing technique wherein commercially thermally sterilized liquid products (typically food or pharmaceutical) are packaged into previously sterilized containers under sterile conditions to produce shelf-stable products that do not need refrigeration. Aseptic processing has almost completely replaced in-container sterilization of liquid foods, including milk, fruit juices and concentrates, cream, yogurt, salad dressing, liquid egg, and ice cream mix. There h…

Historical development in foods

Processing

Packaging material

Effects on food quality

Advantages and limitations

FDA inspection and regulation for aseptic processing

See also