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Βασικά συστήματα για τη συμμόρφωση με την GMP
Στην βιοφαρμακευτική μηχανική καθαρισμού, ο εξοπλισμός απολύμανσης και καθαρισμού είναι κρίσιμες εγκαταστάσεις για να εξασφαλιστεί ότι το περιβάλλον παραγωγής πληροί τις απαιτήσεις της GMP. Παρακάτω είναι 8 συστήματα πυρήνα και οι εφαρμογές τους:
1. Σύστημα συγκράτησης Bibo (Bag-in/Bag-Out)
Το σύστημα BIBO είναι μια συσκευή προστασίας ασφαλείας για την αντικατάσταση φίλτρων HEPA, συμμορφώνοντας με τα πρότυπα Cleanroom ISO 14644-1. Βασικά χαρακτηριστικά:
·Πλήρως κλειστή λειτουργία για την πρόληψη της εξάπλωσης μόλυνσης
·Κατάλληλο για ντουλάπια βιοασφάλειας και συστήματα HVAC
·Συμπεριφορά με την ΕΕ GMP Παράρτημα 1 Σχετικές απαιτήσεις για αποστειρωμένα προϊόντα
2. Καθαρισμός σταθμού εργασίας
Εξειδικευμένα συστήματα καθαρισμού που έχουν σχεδιαστεί για σκεύη καθαρού χώρου, πληρούν τις απαιτήσεις USP <1072> και GMP:
·Ολοκληρωμένες λειτουργίες πλύσης, έκπλυσης και ξήρανσης
·Χρησιμοποιεί WFI (νερό για ένεση) ως τελικό μέσο έκπλυσης
·Συμμορφώνεται με τις απαιτήσεις επικύρωσης ASTM E3106-18
3. Αποστολέας αποστειρωμένου
Κλειστό σύστημα σχεδιασμένο σύμφωνα με το παράρτημα 1: παράρτημα 1:
·Παρέχει αποστειρωμένο περιβάλλον κλάσης ISO 5 (κλάση 100)
·ΣΥΣΤΗΜΑ ΕΝΕΡΓΟΠΟΙΗΣΗΣ VHP (Εξωρυμένο Υδροξείδιο)
·Κατάλληλο για εργασίες με ασηπτική πλήρωση και μεταφορά προϊόντων
4. Απομόριο πλήρωσης πίεσης αποστειρωμένης αρνητικής πίεσης
Ειδικά σχεδιασμένο σύστημα απομονωτή συμβατή με:
·Η καθοδήγηση της Aseptic Processing US FDA (2004)
·Διατηρεί αρνητική πίεση για την πρόληψη της διασταυρούμενης μόλυνσης
·Ολοκληρωμένο σύστημα παρακολούθησης σωματιδίων στο διαδίκτυο (PMS)
5. Σύστημα αποστείρωσης VHP HVAC
Διαλύμα αποστείρωσης HVAC με βάση το υπεροξείδιο του αθυλάματος:
·Συμμορφώνεται με το πρότυπο επικύρωσης αποστείρωσης ISO 14937
·Επιτυγχάνει μείωση 6-log του Geobacillus stearothermophilus
·Κατάλληλο για αποστείρωση καθαρισμού βαθμού Β και C
6.
Ειδική συσκευή μεταφοράς για αποστείρωση κουκούλας καθαρισμού:
·Συμμορφούμενη με το πρότυπο IEST-RP-CC003.4
·Ολοκληρώνει τον κύκλο αποστείρωσης εντός 30 λεπτών
·Σύστημα ενσωματωμένου βιολογικού δείκτη
7.
Σύστημα παραγωγής GMP ειδικά σχεδιασμένο για προϊόντα κυτταρικής θεραπείας:
·Συμπεριφορά με τις απαιτήσεις FDA CGT (2020) και EMA ATMP
·Ενσωματωμένη μονάδα εκκολαπτηρίου CO₂ και κρυογονικής λειτουργίας
·Πληροί τις απαιτήσεις ηλεκτρονικών αρχείων 21 CFR μέρος 11
8.
Επαγγελματικός εξοπλισμός καθαρισμού που πληροί τις απαιτήσεις του Παράρτημα 1 GMP:
·Η επικύρωση PQ συμβατά με το πρότυπο ASTM E3106
·Παρέχει ανιχνεύσιμα αρχεία καθαρισμού
·Κατάλληλο για καθαρισμό από ανοξείδωτο χάλυβα και πλαστικά σκεύη
Σχετικά διεθνή πρότυπα:
·ISO 14644-1: 2015 Cleanrooms και συναφή ελεγχόμενα περιβάλλοντα
·Παράρτημα ΕΕ GMP 1: 2022 Κατασκευή Αποστειρωμένων Προϊόντων
·USP <1072> απολύμανση καθαρών χώρων και άλλων ελεγχόμενων περιβαλλόντων
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