Liyofilizasyon: Genel Proses Değerlendirmesi
Liyofilizasyon veya bir diğer adıyla dondurarak kurutma, final ürün özelliklerini, stabiliteyi ve verimi etkileyen kompleks bir proses olarak kabul edilmektedir. Liyofilizasyon, zorluklarına rağmen sunduğu avantajlar nedeniyle zoonoz hastalıkların da yer aldığı birçok hastalığa karşı uygulanan aşıların üretim zincirinde yer almaktadır. Aşılar diğer biyolojik maddeler veya mikroorganizmalar liyofilizasyon dışında, soğutma veya dondurma ile stabil hale getirilebilirler. Fakat ürünlerin donmuş fazda taşınması ve depolanmasının yüksek maliyeti yanında olası sistemsel arızalar ürünün yapısını bozarak kaybına neden olabilmektedir. Bu açıdan liyofilize formulasyonlar daha iyi stabilite avantajı ile birlikte, taşıma ve depolama sırasında da kolay idare sağlamaktadırlar. Bu derlemede, liyofilizasyon metodunun genel proses değerlendirilmesi yapılarak, prosesi oluşturan, dondurma, birincil kurutma ve ikincil kurutma basamakları arasındaki etkileşim açıklanmıştır. Canlı aşıların üretiminde önemli bir proses olan liyofilizasyon, prosesi uygulayan araştırmacıların gözünden değerlendirilmiş, üretim ve liyofilizasyon faaliyetlerinde bulunan çalışanlara yönlendirici ve destekleyici bilgiler paylaşılmıştır.
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