Tag Archives: Parker

New Challenges Faced by the Brewing Industry

The brewing industry has recently undergone several significant changes. The craft beer market has exploded and, the average beer drinker has developed more sophisticated tastes, opting for higher quality beers. Brewers are looking to expand their business by exporting their product to distant consumers. All the while, the cost of energy, water, and hops  has increased putting breweries bottom line profits at risk. In order to navigate these market shifts, stbreweries must adapt their method of production in order to create a high-quality product, which prioritises flavour and characteristics to appeal to the sophisticated consumer, whilst reducing process costs and increasing the shelf life of their product in order to stermaintain the products stability- so beer reaches the consumer as fresh as it was when it left the brewery.

So, here’s the question, how can brewers make a better tasting beer, with a longer shelf life all whilst reducing the cost of production?

Innovation is the answer

To overcome these challenges, breweries must look to implement innovative solutions throughout their brewing and packaging processes. Recent years have seen the emergence of technologies which can benefit the flavour, cost and shelf life of beer. However, beer has long been considered a combination of art and science, and some brewers are reluctant to switch from traditional methods of brewing to modern scientific methods. However, an increasing number of breweries from the local craft brewery to the global goliaths are discovering the benefits of modern sterile filtration as a method of microbial stabilisation.

Sterile filtration of beer

The sterile filtration of beer is a method of microbial stabilisation which eliminates unwanted contaminants such as Pediococcus damnosus, Brettanomyces bruxellensis, Lactobacillus lindneri and lactobacillus brevis from beer prior to packaging. The microbial stabilisation process and the subsequent elimination of spoilage organisms greatly increases the shelf-life of beer when compared to beer which has not been treated, enabling brewers to ship their product to consumers at greater distances over longer periods of time.

Brewers have historically used other methods of microbial control such as flash pasteurisation, however, these practices have their limitations. The method of flash pasteurisation involves cooking beer, which has been painstakingly brewed with time and care, up to a temperature over 70oC for a short period of time. This process does denature spoilage organisms within the beer, but also damages the delicate flavour and characteristics of the beer.

Sterile filtration is the gentler alternative to flash pasteurisation. The implementation of sterile filtration eliminates all spoilage micro-organisms but does not alter or damage any of the desired characteristics and flavours the master brewer achieved.

What’s more, sterile filtration has a lower operating cost compared to flash pasteurisation due to the high electrical energy consumption required to heat such large volumes of liquid to 70oC, the consequential water consumption and beer loss experienced when flash pasteurisers deviate from critical flow rate – a common issue for brewers running flash pasteurisation.

To find out more about sterile filtration, sign up to our webinar “Extending Beer Shelf-Life While Reducing Processing Costs” which will be held on the 16th of April.

Process Protection – What Does It Mean To You?

Guy Matthews, market development manager at Parker domnick hunter, explores what process protection means for biopharmaceutical manufacturers… and examines how supply chains can be made more robust.

Imagine the scenario. Your new blockbuster drug is making a significant difference to the lives of patients. But then your supply chain fails, taking the product out of circulation. The consequences for patient health – plus the damage to your reputation as a biopharmaceutical manufacturer – would be catastrophic, even before you consider the economic impact. Given the investment that has been put into the development of a production process – in both time and resources – it’s vital that the process can be implemented in a way that is as repeatable and predictable as possible, and that the risk of contamination, process failure or production shutdown is minimized.

As a biopharmaceutical manufacturer, you may have employed elements of quality by design (QbD) to established limits of operation, taking into account critical quality attributes (CQAs) but is process protection built into your operations? And what does it mean?

Protecting your process from contamination

Contamination is one of the most obvious ways in which a process can be compromised. The presence of a biological contaminate for example a mycoplasma, virus or bacteria can result in a reduced yield or the complete loss of a batch.

However, there are a number of ways in which contamination can be combated, including the use of:

• Mycoplasma retentive filters when processing mammalian cell culture media
• Bioburden reduction filters at key stages of the process
• Fully enclosed processing, making use of single-use technology
• Viral risk mitigation treatments such as HTST (high temperature short time)

System failure protection

Mitigating against the risk of production system failure and the resulting unplanned downtime also forms an important part of process protection, resulting in a secure supply chain.

You would not run a car without having it serviced regularly and biopharmaceutical manufacturers should also have a service support plan in place for identified pieces of critical equipment. This will ensure the system is running in an optimal state.

Also essential – though sometimes overlooked – is the importance of quick access to critical components. The additional investment in critical spares (whether they are components or fully assembled systems ready to be brought into play at a moment’s notice) would normally be at a significantly less cost than that incurred by an unplanned plant shutdown due to component failure and the inability to replace it. Linked to this is the need to ensure access to source codes for automated equipment. Such systems would ideally run on an industrial platform rather than a vendor’s bespoke solution, allowing support from more than one source.

The purchaser/vendor relationship

As a biopharmaceutical manufacturer, the relationship you have with your vendor can also shape your ability to protect your processes and guarantee operational continuity. Having a supply agreement with the appropriate service level agreement in place is a good starting point, as is ensuring that the vendor has a comprehensive disaster recovery plan, which could include (but not be limited to) the flexibility to offer manufacturing at dual sites.

But consider this. If your plant is made from stainless steel and a SIP cycle fails, it can be repeated – albeit with consequences for lead times. The use of single-use systems in bioprocessing changes the landscape: no process can be put into operation unless you have available to you the assemblies that make up that process. Put simply there is no product if there is no process.

In this environment ensuring that the supply chain is robust is critical and the relationship between the purchaser and vendor should go beyond placing orders and waiting for deliveries.
Having a two-way conversation and treating the relationship as a partnership, rather than simply viewing the vendor as a commodity supplier, can have significant benefits for process protection.

As a biopharmaceutical manufacturer, sharing information with a vendor on your manufacturing forecasts, for instance, can help the vendor to predict demand for stock, and plan production of key components, part-finished assemblies or indeed, finished systems around this forecast. This will enable the end user to access stock at the appropriate time rather than risking the consequences of a long turnaround time for delivery.

You may also consider holding stock in line with your own production forecasts and putting in place a contingency against product or process failure. Standardization can help here. If common parts are used in more than one process then the need for a contingency can be reduced.

In addition, a closer vendor/purchaser relationship will help to prevent any issues surrounding unrealistic expectations around delivery times, and support the development of a more holistic approach to the supply chain by all parties ensuring the supply of life saving products.

Contributed by Guy Matthews,  Market Development Manager at Parker Domnick Hunter

Join Parker Domnick Hunter on 13th June for their webinar entitled ‘Protect The Process; Protect the Patient‘ for more information on Process Protection.

Register Here

Is Innovation the Key to a Single-Use TFF Future?

Parker Webinar

Advances in technology are allowing biomanufacturers to move to entirely single-use set-ups for tangential flow filtration and benefit from the many advantages of single-use technology. Tangential flow filtration (TFF) is a common operation in the manufacture of biopharmaceuticals and has traditionally been performed using reusable cross flow filters installed in stainless steel systems. Innovations in single-use technology can bring many benefits to biopharmaceutical TFF operations.

TFF applications in bioprocessing

Tangential flow filtration applications are typically divided into microfiltration or ultrafiltration applications depending on the cut-off of the membrane used. Microfiltration is often used to effect solid-liquid separation, such as the clarification of E.coli lysates or even mammalian cells. Ultrafiltration is more commonly associated with the concentration and diafiltration of soluble biopharmaceutical products, such as recombinant proteins and monoclonal antibodies, either during their purification or at the end of the purification process to prepare the product for filling operations.

Drivers for switching to single-use setups for TFF operations

1. The solutions and steam required for cleaning and sterilizing reusable filters and systems need to be generated by installing dedicated equipment with a capital and running cost.

2. Validation of the steaming and cleaning regimes takes time and delays the speed with which new biopharmaceutical products reach the market.

3. There is a risk of product cross contamination in multi-product facilities because, even if the filters are dedicated to a particular product, the equipment itself is unlikely to be.

4. Stainless steel systems are inflexible and difficult to modify. This is especially a problem during the development of the process when optimum configurations are being identified, but it can also represent a challenge post-approval if continuous improvement activities identify configuration optimization opportunities.

Innovations in technology are now allowing biomanufacturers to switch from stainless steel TFF operations, and their associated challenges, to entirely single-use set-ups.

Innovations in single-use technology

1. Single-use, gamma-irradiatable TFF filters

2. Pilot and 21 CFR Part 11 compliant single-use automated systems

3. Fully disposable fluid flow paths

4. Single-use sensors for measuring critical processing parameters

Single-use automated TFF solutions are fully scaleable from lab to GMP manufacturing and increase flexibility during process development, delivering more optimized processes. With reduced assembly, set-up and tear down time, manufacturing productivity is enhanced while capital investment in utilities, plant and time to market is reduced. Importantly, these benefits can be achieved while increasing quality through minimizing cross contamination risks, delivering a higher level of control and standardizing the operators’ experience.

To learn more, register here for Parker’s webinar.

This post was contributed by Nick Hutchinson, Market Development Manager (Pharma & Biotech) at Parker domnick hunter Process Filtration, UK.

Parker domnick hunter, specializes in automating and controlling single-use processes. By integrating sensory and automation technology into a process, a manufacturer can control the fluid flow more effectively, ensuring the quality of the final product. Find out more about Parker domnick hunter’s single-use TFF solutions.