In order to prevent the product from oxidation, the space above the liquid level in the container can be purged with inert gases (nitrogen, carbon dioxide).
Type of Containers which can be made on the machine
The process is versatile and a wide variety of containers of different sizes can be made on the machine. The size may range from 0.2 ml to 13 litres. For convenience, the sizes of containers are classified in the following three categories:
Multi cavity mould
Incorporated vacuum generator
Product range from 0.2 ml to 13 lt
The containers can assume a wide variety of shapes and they can be very rigid or quiet flexible as to render the container squeezable. The liquid is usually dispensed from the top of the container, and to facilitate dispensing, the top of the container can have a different shape and can even be threaded to affix a connector or a cap.
Multi-cavity moulds in stainless steel and special bronze alloys, with advanced cooling and vacuum circuits machined within the mould, enable the production of uniform containers (bottles, vials, ampoules).
Moulds can be graduated to indicate remaining liquid in the container. Inserts are provided for batch coding and embosing of company logo on the container surface.
A special elevator with hydraulic movement allows an easy handling of the mould.
Materials Used for Machine Manufacturing
Judicious use of material in contact with pharmaceutical liquids and self-lubricating parts allow the machine to function in pharmaceutical clean rooms for primary packaging and guarantee optimal performance under corrosive conditions. The ergonomical layout of components gives easy access for maintenance and cleaning purposes.
Incorporated vacuum generator and de-flashing unit
Machines are equipped with a vacuum generator and an automatic deflashing device, while the hydraulic system is provided with electronically regulated proportional control valves for smoother operation.
Control system & Man Machine interface
The control system performs following functions automatically:
1. carries out SIP, CIP, filter drying and maintenance of the sterile status.
2. performs preliminary activities necessary for the execution of filter integrity test.
3. controls, executes and monitors the complex automatic cycle of extrusion, blow moulding, filling, de-flashing and delivery of the containers.
4. executes, controls and monitors the manual commands, in the manual mode.
5. monitors and records critical parameters of machine functioning. If any performance parameter is out of limits, it provides audio and visual signals to draw the attention of the operator. It also records these out of specification events in chronological sequence for record.
The Man Machine interface is composed of a keyboard, control panel and a colour monitor. It has several levels of access, hierarchical as well as horizontal categories are built in for access control.
Man Machine interface
Man Machine interface allows following:
1. it allows operator to set desired parameters for SIP, CIP, filter integrity and other parameters like temperature of extruder, and time allowed for steps of machine cycle. Wherever relevant, upper and/or lower limits of the parameters can also be set by a maintenance engineer through the interface.
2. it allows viewing of the parameters necessary for functioning of the machine.
3. it allows current production data like hours of operation, quantity of the solution consumed, quantity of plastic consumed, etc.
4. it allows viewing of critical parameters like temperature, pressure, etc. during SIP, CIP and other important machine preparation steps.
5. it allows viewing, recording and saving of alarms, current as well as past.
6. it provides indications to carry out certain maintenance activity.
7. it allows viewing and setting of mechanical parameters for movements (mould closure and carriage movement, pins and nozzle movement).
Blow-Fill-Seal technology was mainly developed for pharmaceutical applications, but it can also be used for primary packaging of:
• fresh fruit juice.
• fresh milk.
• non aerated drinks.
• cosmetic products.
What can be filled
Apart from pharmaceutical liquids, which are mainly aqueous solutions, modified filling systems can be developed to package pastes, creams, thixotropic substances, substances which set very quickly, substances which need protection from light and from atmospheric oxygen, etc.
With Blow Fill Seal technology the final packaged product is:
• cost effective.
• particulate free.
• microbiologically pure.
• contamination free.
• in modified atmosphere.