ROMMELAG 321 Blow, Fill, Seal Machine

Stock No. 2124

Blow-Fill-Seal packaging systems are adaptable to the customer’s specific production requirements and replace the three separate machines that are normally required at this stage of production.

The defining characteristic of the Blow-Fill-Seal Process is the sterile moulding of the bottles or ampoules directly from the extruded plastic in water cooled blow moulds followed by immediate sterile injection of product and hermetic sealing of the container under aseptic conditions all in the same machine.

This assures high process reliability and product security. In addition, the design flexibility of the containers with integrated moulding of the head closure and in-mould coding are a great convenience to the user. This technology guarantees a very low level of particulate contamination.

The machine we are offering was purchased new from Rommelag and commissioned in 1998/9

The equipment provides:

Vacuum transfer of polypropylene resin pellets from bulk container crates (1500lbs/680Kgs) with built-in hydraulic tilting device.
 
The forming unit, currently set to form 20ml or 50ml bottles, 8 cavities per cycle.  

A Laminar Air Flow unit above

A Take off unit, transfer to collation unit, check-weigher and end of line packaging.

Bottles are formed using pure polypropylene granules (commonly used for sterile pharmaceutical products) Polyethylene is easier to use but not suitable for terminally sterilised products.

The Blow-Fill-Seal Process in the machine is as follows:

Extruding
Granules are transferred to a receiving hopper on the extruder which heats and extrudes a plastic parison. This is accepted by the opened blow mould and cut below by the die.

Moulding
The main mould closes and simultaneously seals the bottom. The special mandrel unit settles onto the neck area and forms the parison into a container using compressed air or vacuum.

Filling
The product is precisely measured by the dosing unit and put into the container via a special mandrel. The entire filling process takes place aseptically.

Compliance with cGMP
In the revised EU GMP annex on the manufacturing of sterile medicinal products, a separate paragraph is dedicated to Blow/Fill/Seal technology. It states:

"Blow/Fill/Seal equipment used for sterile production which is fitted with an effective grade A air shower may be installed in at least a grade C environment, provided that grade A/B clothing is worn".

The Laminar Air Flow unit offers the possibility of complying with this requirement.

Sealing
After the mandrel unit retracts, the head mould closes and forms the required seal by vacuum.

Mould Opening
With the opening of the blow mould, the container exits from the machine and the cycle repeats itself.

Transfer
Bottles are then transferred via conveyor to the packing stage