Highlights

• Robotic handling of the nests and tubs grants precise and smooth operations
• No glass-to-glass contacts during filling
• Filling System adopts Peristaltic or Volumetric piston pumps, depending on customer needs
• Possibility of filling different containers with minimum changeover
• High Filling accuracy
• IPC by means of integrated load cells for statistical check weighing

	Sterile filling in vials for liquid products
	Sterile PFS filling for liquid products
	Sterile filling in vials for lyophilized products
	VPHP decontamination system
	Compact footprint
	Suitable for vaccine production
	Full Laminar Air Flow
	All-in-one isolator integration
	Panel PC HMI Control System fully compliant for CFR21 Part11 and Data Integrity requirements

Main features

Combo Phill is designed for aseptic filling of Ready-To-Use nested products such as PFS and vials, for R&D and Pilot Scale sterile production.

All isolators chamber air quality are compliant with ISO5 / Grade A (EU-GMP) and equipped with laminar flow over the entire area.

ROBOTIC HANDLING

A real smart approach

Thanks to its modular design, the filling line is available with different possible configurations in order to fulfil the requirements of different production needs.

Different production cycles possible:

1. Lyo loading;
2. Liquid Production;
3. Lyo unloading & simultaneous syringe production.

The real smart approach to fulfilling all requirements on vaccines production

Possibility of filling nested syringes and vials.

Aseptic Filling via perfect combination between machine and isolators. Integrated VPHP decontamination system. Full process control by HMI.

• Syringes, PFS 1 ml – Nest 100 position @ 1 ml. fill volume: 2500 p/h
• Vials, 6R – Nest 48 position @ 5 ml. fill volume: 2000 p/h
• Capping of Lyophilized Vials @ Up to 6.000 pcs/h, capping only
• High filling accuracy by peristaltic pump
• IPC with statistical check weighing system
• Nitrogen purging before & after filling for vials and syringes

General process cycle

From nest/tubs to filled aseptic vials or pre-filled syringes by semi-automatic or automatic processing. Combo Phill is designed to allow minimal human intervention to reduce contamination risk on your aseptic vaccines production process.

Fully automatic or semi-automatic No-Touch-Transfer procedures grant smooth opening and transfer of the tubs inside the process area.

ONE SOLUTION FITS ALL

De-bagging

Semi-automatic De-bagging

• Superior ergonomics
• Optimized bag cutting system
• Easy reachable bag disposal
• Validated process
• Possibility to integrate camera

Robotic handling

Positive handling of nested products by robotic arm

De-lidding

Fully or semi-automatic Tywek removal & De-lidding

• Foil and lid automatically disposed
• Optimized movement to minimize particle generation
• One Stop operation
• Minimal footprint

Filling & stoppering

Piston or peristaltic filling system available

• Optimum solution for filling different glassware in a nest
• Peristaltic or piston pumps
• Integrated check weighing system
• Nitrogen purging before & after filling

Further available options

• Also available with fully integrated Active ORABS, as an alternative to isolators
• Speedy Glove – Automatic glove tester
• RTP Rapid Transfer Port and/or Sterile Liquid Transfer port
• Piston Pumps instead of peristaltic
• Viable and Non-Viable Integrated Monitoring System
• HEPA H14 1st stage exhaust filtration
• HEPA H14 2nd stage exhaust filtration BIBO Safe Change
• Dedicated HVAC
• Scada interface Predisposition

17 Frequently Asked Combo Phill Questions and their Answers

As we travel to industry events worldwide and present our Combo Phill, there are a few questions from booth visitors that generally come up. Here are the most common ones, with their answers.

1. Why is supporting a variety of containers important?

Having a machine that is not dedicated to this or that type of container allows you to be able to adapt the machine to your production needs.
Often the same drug needs to be packaged in different containers, depending on markets or distribution needs. Working with pre-packaged products in nests and pre-sterile containers fulfils this demand.
Fast changeover provides the ability to quickly change from syringe or bottle even within a few hours.
The use of robots also helps in this sense, as the robot “pincers” (little hands) can handle different nests or trays, without the need for a changeover

2. How fast is the changeover between different drugs/containers?

The use of peristaltic pumps, and therefore of disposable kits, makes it possible to change from product to product very quickly.
The same is true for the format parts, which are generally adjustable or do not require tools.
It is difficult to give an exact indication of the time as it depends on the complexity of the line, but we can indicate that in less than 4 hours it is possible to change format/product and perform a VHP cycle.

3. How much space does Combo Phill need?

The dimensions vary depending on the configuration since it has a modular structure.

4. How does the equipment scale to meet increased filling needs?

The machine itself is not scalable in terms of increased production.
However, the layout is scalable. For example, today I am only making syringes, tomorrow I can add the modules necessary to make vials, and subsequently, I can add the lyophilizer section.

5. What training is necessary to use Combo Phill?

No training is necessary other than what is required for any aseptic line.

6. What automation does it use and why?

The heart of the line, the filling machine, uses anthropomorphic robots with six Cartesian axes, able to manipulate and position any object in space with extreme precision.
We use top-quality robots (Staubli), already used and certified for use in an aseptic environment and resistant to VHP and other chemical sanitizers.

7. When is human intervention needed to operate it?

The operator’s role can be summarized as “supervisor”. The line is automatic and autonomous, the only mechanical operation needed is the feeding of the tubing to the aseptic line.

8. How quickly can Comecer supply this equipment from requirements definition to delivery?

Comecer will deliver the line in 10 /12 months maximum (depending on configurations).

9. What makes Combo Phill different from other pharma filling systems on the market today?

Combo Phill is the ideal solution for small batch production, suitable for different containers such as vials, syringes, and cartridges. Thanks to its modularity and robotic handling it is suitable for filling different containers with minimum changes.

10. Why is Combo Phill suitable for small-scale production?

Small-scale production sites often need to switch containers and products. Today the market offers “ready to use” containers that help the pharmaceutical companies to develop products with limited investment and high safety standards. Combo Phill is specifically designed to work with these containers.

11. How is Combo Phill kept clean?

Combo Phill is an aseptic filling line, for liquid vials, syringes and cartridges. Isolator Technology constantly keeps a Class A environment inside the production area.
The isolators and the enclosed machine automation is sterilized with VPHP (H₂O₂ vapours) before every production cycle.

12. What class environment can it be used in?

Thanks to the application of isolators in the entire process area, Combo Phill can be installed in a Class C background environment, allowing the end-user to reduce the running costs and increasing the safety and quality of the products.

13. What automation does it use and why?

Combo Phill adopts robotic handling of the tubs and nests allowing precise and smooth movement. No glass to glass contact is granted.

14. What formats can be processed with Combo Phill?

Combo Phill is designed to work with any RTU nested products, from all the main glassware manufacturers.
These typically include:

• glass vials from 2ml (2R) to 30ml (30R)
• syringes from 1ml to 5 ml.

Other syringe or vial formats can be analysed in detail to evaluate suitability.

15. What is the production capacity?

Indicative production rates with water-like products are:

• PFS 1 ml – Nest 100 position – 1 ml fill volume: 2500 p/h (filling and stoppering cycles only)
• Vial 6R – Nest 48 position – 5 ml fill volume: 2000 p/h (filling and stoppering cycles only)

16. How is the decontamination cycle done and long does it take?

Usually, one decontamination cycle is used to decontaminate the entire line, from the inlet to the exit, and there’s also the possibility to decontaminate a part of the entire line.
The cycle is fully automatic, it does not need operator supervision and it can be launched during the night shift. In general, the VPHP cycle will need from 3 to 4 hours, including the aeration phase. COMECER will assist the customer in the optimisation of the cycle by performing the Cycle Development and PQ activities at the customer site.

17. What options are available for Combo Phill?

Combo Phill can be equipped with many “nice to have” options, such as:

• Automatic Tyvek removal using the anthropomorphic robot
• Nitrogen purging before and after filling
• Statistical check weighing
• Dedicated HVAC for the filling line
• BIBO housing for highly potent cytotoxic products
• Freeze dryer
• Integrated viable & non-viable monitoring system
• SCADA PC package with 21CFR licences