The plant is able to produce infusion solutions in different types of package, including 250 ml and 500 ml plastic bottles, 250 ml and 500 ml plastic bags, 1000 ml and 2000 ml large volume bags. Primary packaging materials will be used only by the standards permitted on the territory of the Russian Federation, i.e. corresponding to the requirements of normative documents (ND), including sanitary-chemical, toxicological, and biological parameters. The finished product will obtain the "Authorized to use" status only after the following steps: bottling by BFS or FFS technologies, final sterilization, 100% visual inspection, marking and packaging, monitoring for compliance with the requirements of the manufacturer's pharmacopoeial monograph (MPM).
Primary product packaging
BFS (Blow / Fill / Seal) technology
The "blowing-filling-sealing" device is a specially designed device combining a continuous process of package formation from thermoplastic granules filled with product and sealed in one automated complex:
The whole process of extrusion-blowing-filling-sealing and burr removal takes between 12 to 18 seconds depending on the polymer and container size. Since the container is made, filled and sealed inside the automatic machine with its own laminar flow cabinet (contamination class A) without moving molds for positions, and all technological media (product solution, sterile compressed air, etc.) are exposed to the sterilizing filter, the possibility of product contamination is virtually reduced to zero.
FFS Technology (Forming / Fill / Seal)
The process of forming-filling-sealing takes a little more time than BFS technology, but can produce two-compartment bag containers that help significantly increase the shelf life of some drugs by spilling their components in different cameras. In addition, multilayer barrier polymer films are less prone to penetration of oxygen or air that is imperative for a number of drugs when choosing primary packaging material.
Automatic FFS machines
Automatic FFS machines have their own laminar flow cabinet (contamination class A) and all technological media in contact with the product are subjected to sterilizing filtration, so the risk of product contamination is virtually reduced to zero.
Thus, unlike traditional technologies, the “blow-fill-seal” and "forming-fill-seal" technologies allow the following:
- implement blowing/forming - filling - sealing/capping processes for polymeric containers in a single device;
- exclude contamination of the product;
- exclude the influence of the human factor on the product quality during blowing/forming-filling-sealing/capping.
SELECTION OF PRIMARY PACKAGING
Polymer vial sealed with additional cap with rubber disc and first opening control.
Production of bottles with a volume of 250 ml and 500 ml. In the future, the purchase of molds for other special sizes (for example, large volume ones) is possible.
Bag of multilayer film
with one or two ports, sealed with standard stoppers - for amino acid and unstable to oxygen solutions.
Production of packages with a volume of 250 ml, 500 ml, and 1000 ml. In the future, it is planned to purchase equipment for the manufacture of two-section bags.
Large volume bags (more than 1 L) for peritoneal dialysis solutions.