Filling Module
This specific module includes the filling machine prepared to:
Fill all types of oral liquid medicines:
Aqueous based products.
Oil based products.
Suspensions.
Bottle size up to Ø70 mm and 180 mm height.
Bottle complements (such stopper, dropper, cap, capsule, others) up to Ø32 mm.
Filling volume from 10 ml to 250 ml.
Production capacity:
40 u/min (2.400 u/h) on simplex mode.
60 u/min (3.600 u/h) on duplex mode.
Module’s general characteristics as per Base Clean Room Module:
Clean room level:
Dimensions:
External: 5,84 m x 2’35 m x 2’6 m (Length x Width x Height).
Internal: 5,72 m x 2’23 m x 2’5 m (Length x Width x Height).
Classified ISO 8 as per ISO 14644 (Class D GMP).
Clean room panels and finishing as per SAMPU standards.
Technical level :
Technical area installed above including HVAC ducts, cables and piping.
Total combined height of clean room level + technical level is 4,5 m.
Filling Machine Stations
Manual feeding:
For plastic and glass bottles.
Loading and debagging by trays/packs.
Bottles buffer through accumulation turn table.
Buffer designed and manufactured for 5 minutes of autonomy.
Bottles Flushing Station:
Flushing and vacuum of all bottles to eliminate residual particles before filling.
Pharmaceutical Compressed Air (or other inert gas if required) used for flushing the bottles.
Filling station:
Filling theorical tolerance of +2% filling volume.
Buffer tank of 10 liters. Prepared for:
Mixing.
Recirculation.
CIP/SIP.
Filling volume adjustable considering weighing cells feedback.
Weighing verification station:
Tare and gross weight register.
Modes:
100%.
Statistical every ‘n’ bottles.
Calculation of the filled volume.
First complement introduction station (stopper, dropper, others):
Bulk charge.
Buffer system designed and manufactured for at least 15 minutes of autonomy.
Complement introduction through Pick&Place.
Presence checked after complement introduction.
OPTIONAL: Pusher station:
Pusher to help the first complement introduction on the bottle.
Second complement introduction station (cap, capsule, others):
Bulk charge.
Buffer system designed and manufactured for at least 15 minutes of autonomy.
Complement introduction through Pick&Place.
Presence checked after complement introduction.
Threader/Crimping station:
Torque threader or crimping head.
Rejection station:
Rejection system without damaging the product.
Rejection station with robust & error-proof mechanism.
HMI
Information retained with data integrity complying with CFR 21 Part 11.
Prepared to generate:
Batch report.
Alarms report.
Audit trail report.
Remote connection for aftersales services.
Design and Manufacturing criteria
Operable by maximum 2 people.
Bottles input and output height 950 ± 50 mm. Adjustable if required.
All adjustable elements are reachable for the operator from only one equipment's side and adjustable with a numeric value.
Poka-Yoke and fail-safe conception.
According to regulations:
European Commission Vol. 4 EU Guidelines to Good Manufacturing Practice. Medicinal Products for Human and Veterinary Use.
Good Manufacturing Practices of the Food and Drug Administration (FDA).
21 CFR Part 11 “Electronic Records, Electronic Signatures”. Food and Drug Administration Title 21 of the Code of Federal Regulations.
Equipment Directive 2006/42/EC.
EN ISO 14122: Safety of machinery - Permanent means of access to machinery, part 1 till 4.
EN ISO 13849: Safety of machinery - Safety-related parts of control systems.
Documentation
Design documentation.
DQ protocol + report.
As-built documentation:
CE Declaration of Conformity.
Layouts.
Electrical diagram.
Pneumatic diagram.
Datasheet of valves and/or instrumentation and components.
Calibration Certificates.
Operation manual:
Start-up procedure.
Format changeover procedure.
Cleaning procedure.
Alarms list with every troubleshooting.
Maintenance manual.
Spare parts list and fungible assets.
FAT & SAT protocols + report.
IQ & OQ protocols + report.
PQ protocol + report.
The standard language of all documentation will be English.
