Historically, because of the random nature of the nucleation process, lyophilization has been difficult to control. For a typical pharmaceutical formulation filled in vials, for example, crystals might form at temperatures ranging from –5 to –20 °C).
As the nucleation temperature has a direct impact on the developing ice structure and crystal size — as well as the appearance of the dried product cake — it can negatively influence the product’s critical quality attributes (CQAs), such as residual moisture or dissolution behavior.
A new patent-pending technology from GEA, which is fully compatible with all our currently available freeze dryers, provides a novel and scalable method to control the nucleation process without having to develop new pharmaceutical formulations.
Process without LYOSPARK®
Simultaneous Crystal Nucleation
LYOSPARK® enables the user to control the temperature at which nucleation crystals form inside the product, thereby ensuring that, at any time, every vial in the chamber is subjected to the same process conditions, irrespective its specific location on the shelf.Combining LYOSPARK® technology with conventional freeze-drying processes is very simple. The vials are loaded into the freeze dryer as usual and cooled to the optimal (product dependent) nucleation temperature. As soon as the nucleation temperature is reached, the chamber is vented with gas from a condenser.
A filter-equipped cooling trap is mounted on the chamber. Ice crystals form on the cooled surface of the trap and are entrained in the gas stream during venting. Inside the supercooled product solution, the ice crystals undergo immediate and homogenous nucleation in each vial.
As the formation of ice crystals at higher temperatures results in larger pores, drying times can be shortened. Furthermore, LYOSPARK® offers better scalability, sterility and higher throughput speeds than conventional systems, resulting in optimized performance and productivity.
Process with LYOSPARK®
Process Optimization
LYOSPARK®, which eliminates issues such as the denaturation of active ingredients or unpredictable scale-up, also provides several technical advantages, including improved product quality, better vial uniformity per batch and a more homogenous, aesthetically pleasing cake.In summary, LYOSPARK® controlled nucleation technology facilitates uniform ice crystal formation in laboratory and production-scale freeze dryers with a minimum degree of supercooling. This is reflected in more consistent and larger ice crystal sizes with a more open product structure. As a result, faster drying and reconstitution times can be achieved.
QbD-compliant, GEA’s LYOSPARK® delivers a more uniform, higher quality product, reduces process times and provides a cost-effective solution to controlled nucleation.
At a glance advantages
- Larger ice crystals
- Shorter drying times
- Better process control
- Better reconstitution
- Less vial cracking
- Less stress on biological agents
- Better looking cake
This cost-efficient technology will be offered as an option for all GEA freeze dryers and will also be available as a retrofit option for existing plant.
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منتجات ذات صلة
LYOVAC® Pharma Freeze Dryer
GEA’s LYOVAC® industrial-scale freeze dryers are built to customer specifications and are available with production areas of 1–60 m² and condenser capacities of more than 1000 kg.
LYOVAC® Freeze dryers for small scale production modules
LYOVAC® Freeze dryers for small scale production modules
LYOVAC® Small-Scale Freeze Dryers
Extending its range of LYOVAC™ Freeze Dryers, GEA now offers both integrated and standalone equipment for the production of small-scale batches and formulation or process development.
رؤى GEA
The breakthrough that changed spray drying
In 1976, NIRO engineers responded to a competitive challenge by rethinking what spray drying could do. Their idea became the multi-stage dryer MSD. Fifty years later, the same fundamental principle helps turn liquids into the powders used in essential nutrition products and important medicines around the world. Refined through decades of engineering expertise, customer insight and continuous development, MSD is a story of innovation with lasting impact.
ما وراء الآلة: إطلاق العنان لأداء أفضل للمصنع
إن وجود آلة فعَّالة لا يعني بالضرورة وجود مصنع فعَّال. غالبًا ما يبدأ التحسين الحقيقي بالنظر إلى ما وراء المعدات الفردية، وفهم كيفية تأثير العمليات، وأنظمة الطاقة، وقرارات التشغيل على بعضها البعض. إنه نهج شامل يهدف إلى اكتشاف الفرص التي قد تُفوَّت لولا ذلك.
كيف يُحدث الصمام تغييرًا جذريًّا في طريقة تصنيع الأطعمة والمشروبات
في مصانع الأغذية والمشروبات، تُشغّل الصمامات عادةً باستخدام الهواء المضغوط. تعمل GEA Hydract® Actuation Technology على تحريك الصمامات باستخدام الماء بدلاً من ذلك، وذلك ضمن دائرة مغلقة يتم التحكم فيها رقميًا. والنتيجة هي صمام يمكن تثبيته بدقة في مكانه، وتوجيهه بخطوات دقيقة. وينتج عن ذلك انخفاض في استهلاك الطاقة، وتحسين مستوى التحكم.
