5 Incubators, Freezers & Cooling Equipment
The fi nancial and operator benefi ts of utilising controlled nucleation include lower rejection rates due to no risk of foreign material entering the vials, enhanced quality, increased production capacity through shorter cycles, improved safety margin within the design space allowing a batch to be saved if the recipe is disturbed, and GMP compatibility meaning there will be no issues regarding compliance, unlike other technologies. It also allows for scalable technology, from R&D up to commercial scale equipment used for manufacturing, which is also easy to use and operator friendly.
How Has Demand Impacted Production?
To accommodate the trends and demand for lyo in pharmaceutical production, it is now imperative that operators are given the opportunity to utilise freeze drying equipment, designed for use at the R&D level, and capability of replicating process/ software controls in conjunction with fully scalable PAT technology - a necessity when facilitating a ‘QbD’ strategic approach to drug manufacture.
All of the above has lead to recent advancements in freeze drying technology such as the aforementioned ControLyo, SMART and TDLAS processes, as well as development of the Lyostar 4.0 freeze dryer that has been introduced to the UK, Ireland and France by Biopharma Group. This new freeze dryer has been developed to enhance R&D and process development, including scale-up, to improve speed to market of biopharmaceutical products, representing a signifi cant advancement in freeze dryer engineering.
What Does This Mean for the
Pharmaceutical Industry? The combination of advanced equipment, utilising the benefi ts of controlled nucleation and proven methods for improving the lyophilisation production process, ultimately enables the QP to consider whether the product has remained within its known ‘design space’ and safe limits for release, even in the event an issue occurrence during the cycle including unplanned process excursions. This is thanks to a higher level of data integrity becoming available within these advanced processes, highly desirable in the pharmaceutical industry due to the stringent regulations in place.
When also considering the costs associated with the material being processed, the difference between allowing a batch to be released, rather than it being quarantined and rejected, may be up to £1 million. The requirement to ensure as much data becomes available for consideration post-drying, potentially mitigating the risk of batches being rejected is highly sought after, due to minimising risks and yielding higher cost savings.
By being able to obtain the data that expands understanding of the equipment and process design space, when things go wrong (which they sometimes can), back-up information is available to prove batch integrity. Within the ‘Line of Sight’ technologies including ControLyo, other realised concepts such as SMART and TDLAS provide many benefi ts when used throughout lyo production.
SMART provides instant feedback on product resistance, heat fl ow, and product temperature at the sublimation interface. These attributes are critical to understanding long-term product stability. It determines and verifi es your optimised primary drying cycle in three runs or less, whilst eliminating the trial-and-error approach normally involved in developing new lyophilised cycles. This allows researchers to spend more time on value added activities such as cycle optimisation with a QbD approach. It also improves ROI and provides a broader product understanding.
A TDLAS based sensor can be used to measure water vapour concentration and gas fl ow velocity during the freeze drying process. These measurements can be combined to calculate the instantaneous water vapour mass fl ow rate and the ice sublimation rate. This allows the user to assess freeze dryer equipment capability limits - very useful from a system validation perspective, monitor process and product parameters and develop freeze drying cycles based on QbD procedures. It is applicable to laboratory, pilot and production scale freeze dryers, using a continuous, non-intrusive monitoring of lyophilisation processes. It takes water vapour, concentration, fl ow velocity (V) and water mass fl ow (dm/dt) measurements, providing a continuous mass balance determination, as well as primary and secondary drying endpoints, average product temperature, average product resistance, vial heat transfer coeffi cients, and freeze dryer performance qualifi cation - one particular area of growing popularity being the effective determination tool of vapour choke fl ow. This can be highly important when validating the capability of a machine and identifi cation of this parameter, can support end users to conduct freeze drying cycles within the overall ability of the system, which in turn minimises the risk of batch failure.
The ‘Line-of-Sight’ technologies and latest equipment has enabled an increased understanding and control over the freeze drying process. Industry leading tools are now available that can characterise the freeze drying process from formulation through to full commercial production, providing successful scale-up and technology transfer as production requirements expand.
As a pilot-scale freeze dryer, the LyoStar 4.0 offers superior shelf mapping, rapid shelf freezing, process accuracy and reliability. It also includes an innovative suite of Process Analytical Technology (PAT) tools supplementing SP’s Line of Sight™ technologies. Additionally, an eco-friendly refrigerant gas is used to help comply with sustainability and environmental impact legislation. This break-through technology incorporates the latest innovations in freeze drying to ensure precise process control and reliability. The fl exibility to scale-up or down, is an important aspect in the process for developing pharmaceutical compounds. This equipment allows production to adapt to the demand because of the innovative technology it utilises to help overcome critical lyophilisation challenges during development, scale-up and manufacturing of biologicals, thus also enabling greater sustainability and regulatory compliance.
Having a larger design space or parameters in which to work increases the probability of executing a successful cycle, even in the face of potential problems occurring, including unplanned process excursions.
How Have the Latest Innovations in Freeze Drying Been Applied to Industry?
Throughout the Covid-19 pandemic, there was a huge demand for sterile injectables as well as other essential products such as In-Vitro Diagnostic (IVD) tests. To keep up with demand, increased capabilities and production capacity were applied within Biopharma Group, utilising these recently developed innovations to successfully meet the demand for the high volume of products required on a global scale.
In the near future, this experience combined with emerging equipment, R&D and innovative developments being made within the freeze drying industry, will have a wider impact on the treatment of many diseases and may even start to be utilised within other industry sectors such as nutraceuticals and even food production, in which freeze drying is commonly and frequently applied.
To discover more, contact the specialists at Biopharma Group Read, Share and Comment on this Article, visit:
www.labmate-online.com/article New Heating/Chilling HPLC Column Temperature Controller Announced
Torrey Pines Scientific, Inc announces its new EchoTherm™ Model CO50 Programmable HPLC Column Chiller/Heater. The unit has a temperature range from 4.0°C to 100.0°C readable and settable to 0.1°C. The PID control software regulates temperatures to ±0.2°C, even at ambient. The CO50 has a Stable Temperature LED that illuminates when the target temperature is stable to within ±0.2°C.
The Peltier-based CO50 has 5-program memory of 10 steps per program and the ability to repeat any program from 1 to 99 times automatically. It is ideal for chiral and biomedical chromatography where below ambient temperatures help preserve bioactivity. It can be used for stabilising column temperatures from day to day at or near room temperatures for repeatable results. The CO50 holds columns up to 30cm long by ¼” or 3/8” diameter in mounting clips provided. Larger diameter columns can be used by removing the column clips that hold the smaller columns.
The CO50 features RS232 I/O port for controlling the unit by a chromatograph, for programming gradients, and for data collection. Also included are an injection counter, 30-day timer with user settable Auto-Off, and chamber drain for spills.
The unit comes with a bench top universal power supply for use anywhere in the world, 3-wire AC line cord for the country of use, twelve month warranty and instruction manual. The Model CO50 is UL, CSA, and CE compliant.
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