Commercial Scale High Pressure Homogenisation: Avestin EmulsiFlex C160

by biopharmaszymon in BPS News, BPS Right Sidebar Content

Within the pharmaceutical, biotechnology and industries alike, a common challenge is the replication of results when moving from the laboratory scale to commercial scale.

Many lab scale instruments can differ significantly from the equipment required to produce large volumes of the same material, due to the required characteristics to meet the scale’s demands (e.g. size, durability, materials of construction), and so scalability becomes a frequent issue.

In the field of high-pressure homogenisation, this can be particularly challenging within applications such as:

  • Cell Disruption
  • Particle Size Reduction
  • Emulsions/Nanoemulsions
  • Liposomes

Avestin Inc. address this issue in numerous ways in their industry leading range.

It is a common misconception that a fixed geometry homogenising valve is critical to ensuring scalability of homogenisers. This is not true, and Avestin have shown this via their dynamic homogenising valve, which minimises blockage risk and allows for direct pressure regulation.

The valve geometry remains consistent and scalable throughout the range.

More impressively, each system boasts an incredibly small minimum processing volume respective to its flow rate of sample, allowing a high throughput system to be utilised for smaller scale if needed.

For example, the Avestin EmulsiFlex C160 processes samples at a rate of up to 160L/hr, whilst being suitable for volumes as small as 250 mL.

The C160 has an A version and a B version: The A version can operate at up to 20,000 psi homogenising pressure, whilst the B version operates at up to 30,000 psi. Pressure regulation can be manual or automated. The induced pressure does not impact the machine flow rate – again improving scalability of the process, as well as diagnostics.

The C160 utilises a triplex high-pressure pump system, with each pump operating intermittently, allowing for negligible pressure pulsation. By effectively nullifying this pressure pulsation, an even smoother homogenisation process is created, often reducing the required homogenisation pressure and number of passes to achieve the desired results.

Some examples of impressive results on an EmulsiFlex C160 are shown below:

For stringent temperature control, a sanitary heat exchanger may be connected to the C160 outlet and would act as a high-efficiency cooling jacket with cooling medium pumped through it. Compatibility with water/glycol mixes allows for sub-zero cooling medium temperatures, optimising product recovery.

A cooling system is also present on the triplex pump system, prolonging high pressure seal life. At this throughput, over time, maintenance costs and system downtime are dramatically reduced.

With GMP compliance becoming a more common request, as well as compliance to 21 CFR Part 11, Avestin provide a range of optional extras and certifications, which can be tailored to meet specific user requirements.

Examples of the vast array of options and services available are:

  • IQ/OQ
  • FAT and SAT
  • Validation packages
  • 21 CFR Part 11 Compliant Chart Recorders
  • Aseptic 6-Zonal System Configuration
  • Material Traceability with Certifications

Returning to the note of scalability, for users looking to stick with the triplex pump design, other available units include the Avestin EmulsiFlex C55 (55L/hr flow rate) and the Avestin EmulsiFlex C500/C1000 (500/1000L/hr flow rate).

The C55, despite its high flow rate, can work with volumes as low as 100 mL, and so it can be the perfect lab-scale, triplex pump partner.

Below is a table reflecting some of the common issues that Avestin systems address:

Biopharma Group supply and support Avestin systems in the UK & Ireland, via our own dedicated, experienced sales, service and maintenance teams.

For more information, or to request a quote:

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