Blow-fill-seal plastic containers

The filling of plastic containers is accomplished using two very different approaches. Pre-formed containers can be sterilized in bulk, introduced into the aseptic suite via air locks, oriented (unscrambled), and filled. Blow-fill-seal prepares sterile bottles (most often LDPE) on line just prior to filling and sealing. 

Nebulizer solutions are typically filled as unit dosages in plastic containers. The latter uses blow-fill-seal technology [33]. Thus drug formulation compatibility with plastics is an important factor. Characterization of any sorption processes of plasticizer, monomer, and extractables or leachables is critical during long-term product-evaluation studies. Such sterile unit-dose formulations, in essence, do not require chemical preservation. 

Most plastic ampoules are from the blow-fill-seal types of containers. These containers are formed, filled and closed in one production lane and are therefore not available as an empty container for small scale filling. Some of these plastic containers are known as bottle-pack. These plastic containers are designed for sterile liquid pharmaceutical preparations, which can be opened by tearing, screwing or perforating. The bottle-pack-assortment contains a wide range of containers from ampoules to bottles (1-1,000 mL). 

There are several machine systems available for aseptically filling glass and plastic bottles for still juices. (Aseptic filling of drink cartons is covered in Section 9.7.) Carbonated drinks are not aseptically filled. There are two main aseptic filling workflows, with a third workflow used less frequently. The first system sterilises the container, fills and seals it the second takes a sealed, precleaned bottle, removes the seal in a sterile environment, fills and re-seals the container. The third system blows a bottle and while it is still sterile fills it and then seals it, all within the same machine, this is known as a form-fill-seaF (FFS) system. 

Blow-fill technology is an aseptic process whereby the container is formed from thermoplastic granules, filled with sterile solution and sealed, all within one automatic operation. The bulk solution should have a low bioburden and is delivered to the machine through a filling system that has been previously sanitized and steam sterilized in situ. Concern has been expressed that the machine itself may generate particles. The plastic granules are composed usually of polyethylene, polypropylene or one of their copolymers and are heat extruded at 200°C into a tube. The two halves of a mould close around this tube and seal the base. The required quantity of sterile fluid is filled into the container, which is then sealed. Products packed in this way include intravenous solutions, and small volume parenteral, ophthalmic and nebulizer solutions. The... 

Level Control Filler. Plastic bottles can be manufactured clear thus for consumer appeal, they are filled to a level. This means the volume may vary but will appear to be equal due to the visually perceived common level in the containers. Flow is by gravity through a nozzle into a sealed container, whereas air equilibrates via a vent tube (Figure 8). When the rising liquid reaches the air vent port, flow stops. There is no overflow of product as in a pressure or pure vacuum filler. Aeration is at a minimum, perceived fill level is extremely accurate, and the filler is relatively simple and easy to maintain. Size consistency of the blow-molded container is critical to control, because this dictates the amount of product being sold. 

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