Complete solution for primary packaging of bottles in clinical trials. It enables minimal time between batches in favor of the small batches, usually encountered in pharmaceutical research and development production, and clinical trials.
IN DEPTH
ABOUT
Fully automated and free from format parts, Granitens Flexline Platform, enables minimal time between batches in favor of the small batches, usually encountered in pharmaceutical research and development production, and clinical trials.
This Graniten Flexline application is a primary packaging line for bottles, used by a clinical trial customer. The same technology or modules can also be used or scaled up for routine production, reducing the quality risk of introducing a new type of process.
The modular and scalable platform, has a close-to-zero (C2Z) changeover time, allowing for an efficient and agile move towards personalized medicine, and ’batch size one’.
This Graniten Flexline example, handles the primary packaging step of filling, and capping plastic bottles, leaving the line as traceable bottles.
The 8 modules selected, correspond to the customer’s specific process needs, but can be altered to fit your process.
- Handling minimum 9 types of bottles (3 round, 6 rectangular), for this example with ø 40-60 mm, and H 60-120 mm.
- Packaging minimum 5 types of caps.
- Scalable & upgradeable – new modules can be easily added or upgraded at a later stage, thereby extending the life of the investment.
- One HMI controlling the entire line, and communicating to the local MES system.
main processes:
- Bottle unscrambling
- Bottle air rinsing
- Desiccant dispensing
- Tablet inspection, counting, and filling
- Manual station (if required)
- Bottle capping
- Cap induction sealing
- Cap retorquing
- Outfeed, reject, and sample point
main features:
- Close to zero changeover time
- Tailormade, modular set-up
- Scalable and upgradable as requirements change or new type of containers are introduced
- Minimal footprint
- Low environmental impact, because of high reusability
- GMP compliant design
TECHNICAL DATA
FORMAT FLEXIBILITY:
- Bottle – cuboid (LxWxH): min 40x35x60 mm, max 55x45x120 mm
- Bottle – square (LxWxH): 45x45x80 mm
- Bottle – round (ØxW): min 40×60 mm, max 48×80 mm
- Cap (ØxH): min 35×17,5 mm, max 45×17,5 mm
- Closure (ØxH): min 34×29 mm, max 45×29 mm
- Canister and sachet: A broad range provided
MACHINE DIMENSION RANGE:
- Length 6,75 m
- Width 1,8 m
- Height 2,4 m
CAPACITY:
15 ppm
TECHNICAL CHANGEOVER TIME:
< 3min allows for minimal order sizes
Harnessing automation in the clinical trials process
In this post you will learn more about the clinical trial process. But also, why a Graniten customer choose to streamline their process of clinical trials with automation.