Industrial Machine Vibration Analysis and Condition Monitoring

Cell culture media is a key component of upstream bioprocessing needed to encourage the growth and survival of cells. This is vital to achieving a viable cell density and, ultimately, the desired product titre. However, its filtration can be a challenge for biopharmaceutical manufacturers. 

Cell culture media is a complex mixture and typically contains up to 60 ingredients. However, the exact composition will differ based on the media chosen for the specific application.

Media is usually supplied either as a powder, concentrate or working solution. If a powdered media is used, it must be mixed and sterilized on site prior to use. 

Cell culture media can be categorized into several different formats based on its composition:

 

Serum

Serum is a nutritionally and protein-rich substance derived from animal blood. Serum containing media was once seen as essential for good cell growth and proliferation, however, the desire for animal component-free media due to concerns about contamination and regulation have led bioprocesses away from this media type. 

Serum is also expensive and as it is a natural product, it is by nature uncharacterized and is prone to a high degree of variation.

 

Serum-free media

Serum-free media often contains proteins/protein hydrosolates and, while it is more characterized than serum-based media, it may still contain components derived from animal sources.

 

Animal-derived component-free media

Animal-derived component-free media offers an alternative to serum media. It uses non-animal derived proteins and hydrololates available from soy, yeast or other non-animal-based sources.

 

Protein-free media

Protein-free media allows greater chemical definition of the media's make up.

 

Chemically defined media

Chemically defined media aims to eliminate variation by using only fully defined components - these may be animal-derived or animal-free depending on the media.

 

Whichever media is used, a compromise must be found between safety, characterization and performance. Robust supplier quality assurance is needed to ensure traceability and the procurement of contamination-free media. 

The media will ultimately be chosen to suit the process. 

 

So, what is cell culture media composed of?

Depending on how characterized the media is, the concentrations of components and exact composition may vary lot-to-lot. Different medias will also have different compositions. 

 

 

The ingredients in cell culture media provide a rich nurturing environment for the cells biopharmaceutical manufacturers wish to propagate. Unfortunately, that kind of environment is a place in which bacteria or other unwanted microorganisms can flourish.

 

The role of filtration

Filtration is commonly used to protect cell culture media from contamination. If the powdered media is prepared on site, it will be prepared in a mixing vessel. Components such as water will be filtered to remove contamination prior to entering the vessel and any air and gas or venting will be protected using gas filters. 

Prior to entering the bioreactor itself, the media will be filtered to ensure its sterility - and to, therefore, protect the bioreactor. This filtration may involve prefiltration as well as sterilizing-grade filtration or Mycoplasama removal filtration, depending on the process. 

0.2 micron rated validated sterilizing-grade filtration is used to achieve sterility, or if Mycoplasma contamination is of concern. 0.1 micron rated filtration validated for Mycoplasma removal should be used. Depending of the process and media, prefiltration may also be required. 

The correct design of this filtration system is crucial in optimizing the process. The design must take into account:

• The required retention of the filters.
• The sizing of the filters to ensure the required throughput can be met.
• The flow rates the filters are capable of to ensure the process can be carried out within the available time.

 

The challenges of cell culture media filtration

A number of issues can arise in the cell culture media filtration process:

• If the filters have not been sized correctly, this can result in a low flow rate - and, therefore long processing times.
• Filters may foul or block prematurely. This can be due to a variation in raw ingredients, an excess bioburden in the process, or the filtration system being too small for the batch size.
• If a process is at risk of Mycoplasma contamination, contamination may occur if a 0.1 micron Mycoplasma retentive filter isn't used.

However, these issues can be mitigated by optimizing the filtration system correctly.

Parker supports biopharmaceutical manufacturers in filtration system optimization through testing, process trials and validation as well as technical support for existing systems. We have an extensive range of filters designed for cell culture media filtration including PROPOR SG, our standard 0.2 micron sterilizing grade product, PROPOR HC, our high capacity sterilizing grade product for difficult to filter or variable medias and PROPOR MR 0.1 micron filter designed for use in processes where Mycoplasma contamination is a concern. 

 

For more information on cell culture media filtration, view our recent webinar: Optimization of Cell Culture Media Filtration in Bioprocessing

 

 

What are your biggest challenges in sterilizing filtration media? Let us know in the comments below.

 

 

This post was contributed by David Heaney, market development manager, Parker Bioscience Filtration, UK

 

Parker Bioscience Filtration specializes in automating and controlling bioprocesses. By integrating sensory and automation technology into a process, a manufacturer can control the fluid more effectively ensuring the quality of the final product. Visit www.parker.com/bioscience to find out more.

 

 

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The microbial stabilization of beer is of critical importance for the shelf-life of beers – and as beers are exported all over the world, it’s vital that their original characteristics still remain intact when they arrive in the glasses of thirsty consumers in faraway markets. 

An increasing number of brewers are turning to sterile filtration as a reliable method to ensure a longer shelf-life of their packaged beer. Indeed, many brewery operations have been moving away from flash pasteurization – the traditional method of removing spoilage organisms – due to its negative impact on the flavour profile of the end product and the many advantages offered by sterile filtration.  

 

Filtered beer retains unique and desirable characteristics

It has been shown that beer which has been filtered to achieve stabilization retains its unique and desirable characteristics more efficiently than beer stabilized through flash pasteurization: the sterile filtration process is gentler, compared to the harsh process of flash pasteurization. Sterile filtration can also have a beneficial effect on taste characteristics throughout the duration of the beer’s shelf-life. 

 

 

And there are more advantages too. 

• The performance of sterile filtration can more easily be monitored, because of the relative simplicity of cold stabilization systems.  
• The filters used in sterile filtration minimize adsorption of desirable components and help to protect beer head retention. 
• Beer losses when using sterile filtration can be significantly lower than flash pasteurization.  
• Sterile filtration uses less energy than the flash pasteurization process – as it does not require plate heat exchangers. 
• Water consumption is reduced, as sterile filtration does not necessitate a buffer tank. 
• Sterile filtration requires fewer parts, making the systems easier to operate than flash pasteurization systems.  
• Pasteurization hardware is large and expensive in comparison to the lower initial outlay for a sterile filtration setup. 

 

Partnerships deliver a better product

Parker Bioscience has built a partnership with Agidens Process Automation that combines more than 50 years of brewing filtration experience and industry-leading products to deliver a better beverage. Starting with Parker Bioscience Filtration's detailed knowledge and experience of brewing processes and automation, Parker offers cutting-edge technology for use in sterile filtration. Using this technology, Agidens is now offering a platform of sterile filtration/cold stabilization modules to suit a range of beer flow capacities and specifications, as a more efficient alternative to pasteurization.    

  Sterile filtration in practice – Zagrebačka pivovara installation 

The combined experience of Agidens Process Automation and Parker Bioscience Filtration was recently brought to bear for Zagrebačka pivovara in Croatia, which is part of Molson Coors. Zagrebačka pivovara wanted to expand its range with a premium, non-pasteurized lager and needed to work with a provider with proven expertise in cold stabilization technology. 

It commissioned Agidens to implement a Cold Stabilization Module (CSM) at its brewery site in Zagreb, Croatia. In just five months, Agidens’ engineering team was able to provide a tailor-made CSM solution that was integrated into the brewery’s existing production line.

The CSM installation consists of three modules for a total length of 6.75 metres:

• Filtration skid 
• Distribution cluster 
• CIP skid

The site was only accessible via a small elevator which meant that the CSM had to be custom-designed, disassembled and transported before it could be re-built and installed on site.  

The CSM installed at the Zagrebačka pivovara site filters an average of 250 hectolitres of beer per hour. 

The CSM uses Parker Bioscience Filtration’s PREPOR NG and BEVPOR BR filters in a combination to achieve microbial stability whilst protecting the taste characteristics of the premium lager.  

 

The BEVPOR BR range of filters is constructed with a unique Polyethersulphone (PES) membrane, offering a long service life and therefore a highly efficient solution with a low cost of operation in sterile filtration of beer applications. 

 

Parker Bioscience Filtration’s PREPOR NG filters have been specifically developed to remove yeast and particulate such as filter aids and haze components. The superior level of retention ensures that a consistent quality of the brew is delivered and provides a greater level of membrane filter protection during cold stabilization. 

 

 

 

 

 

For more information on Parker Bioscience Filtration’s sterile filtration solutions for the brewing market visit our website.  

 

 

 

 

This post was contributed by Lee Pattison, Food and Beverage Product Manager, Parker Bioscience Filtration, United Kingdom.  

Parker Bioscience Filtration offers filtration solutions to protect the quality and taste of beverage products. By working with our application experts, manufacturers can develop a tailored solution to ensure their beverage is free from contamination, full of flavour and visibly clear. 

 

 

Related content

The Benefits of Changing Your Microbial Stabilisation Process to Sterile Filtration

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Sterile Filtration of Beer - The Impact on Quantity and Quality

Sterile Filtration of Beer - Saving Water, Saving Energy

How to Protect Beer Quality at the Lowest Cost

With six decades of experience and hard-earned know-how, Bob Brooks is an expert in residential and commercial site preparation. He began operating equipment at just 14 years old and for the past 40 years he has owned his own business. He has customers throughout the Puget Sound and keeps his calendar full through strictly word-of-mouth promotions. Over the course of his 60-year career, he has utilized a wide variety of attachments — and nothing he has used compares to Parker’s Helac PowerGrip® Multi-Purpose Jaw Bucket in regards to productivity.

At current fuel prices, saving 1/2 gallon per hour adds up to more than $2,000 saved every 1,000 machine hours. Their transportation costs of moving machines between job sites have also decreased by shaving 12,000 pounds off of B and B Excavating’s payload.

 

PowerGrip outperforms the competition

Brooks is admittedly tough on his PowerGrip. The sites he clears in the lush Pacific Northwest climate are full of fast-growing evergreen trees, glacial till and more. B and B Excavating previously used cylinder-style jaw buckets and found that they were frequently damaging cylinder-rods and plates when working in rocky soil or digging out concrete foundations. Brooks also disliked the cylinder-style jaw bucket's wasted space in the bucket — with the mounting cross tube on the jaw frequently in his way. With PowerGrip, all the moving parts are fully-enclosed and there are no obstructions in the bucket shell.

While using a thumb combination he grew frustrated by the weight penalty at the end of the boom. B and B Excavating also suffered from inefficiencies like having to take the time to get the bucket under a stump and then pinning the stump with the thumb before working it out of the ground. When grabbing material with PowerGrip, Brooks could just drop down on the object with an open jaw, close the jaw and remove the object. ‘‘PowerGrip offers more control over picking and placing material than anything I have used," said Brooks.

Brooks also values PowerGrip’s ability to seamlessly switch between tasks on the job site. "The PowerGrip really impressed me with its versatility. One minute I am moving heavy boulders or taking down a tree — the very next minute I am grabbing and loading old brittle concrete without breaking it,” explained Brooks.

 

  A powerful and durable solution

PowerGrip is equipped with a durable, enclosed rotary actuator hinge that's ideally suited for the toughest conditions. Parker’s Helac rotary actuator hinge technology offers 120 degrees of smooth jaw movement and constant clamping force. The jaw rotation is generated by the massive rotating pivot point between the jaw and back of bucket that’s designed with the Helac sliding-spline operating technology, which converts linear piston motion into powerful shaft rotation. The end caps, seals and bearings work in unison to keep debris and contaminants out of the inner workings of the actuator, prolonging life and reducing required maintenance. High strength, abrasion resistant steel is used throughout for added durability.

PowerGrip buckets are available for equipment between the 4-20 tons class, with bucket width ranges from 24 inches to 48 inches in the trenching and excavating profiles and 48 inches or 60 inches in ditching and grading profiles.

 

The PowerGrip really impressed me with its versatility. One minute I am moving heavy boulders or taking down a tree — the very next minute I am grabbing and loading old brittle concrete without breaking it,” according to Brooks.  “I’ve used a lot of different hydraulic thumbs and cylinder-style jaw buckets in the past, but to me, nothing on the market compares to the versatility and productivity of the PowerGripl/Multi-Purpose Jaw Bucket.

 

-Bob Brooks, owner, B & B Excavating

 

Download the brochure for more information on PowerGrip.   

 

This article was contributed by Jessica Howisey, marketing communications manager, Helac Business Unit, Cylinder Division

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