Fill and Finish Operations - - BioPharm International


Fill and Finish Operations

BioPharm International

BFS allows different shapes, sizes, and dispensing designs. Extended tabs at the base of the container can add additional labeling area. Containers can be embossed with product name, lot number, and expiration dates. Product can be packaged in multiple attached vials or single-dose regimes. Medical insurance reimbursement sometimes dictates packaging so that five cards of six ampoules are in a carton as a 30-day supply, rather than seven ampoules for a one-week supply. Many closure designs are possible (such as the Luer-lock for single-dose parenterals), elastomeric closures for multiuse parenterals, and closures for pharmaceutical dispensing needs.

Peripheral equipment can include container conveyors to move the product through each in-line accessory, inspection cameras measuring the fill-level height, a vision system against cosmetic defects, and a deflashing unit to remove excess plastic (flashing) that can be recovered, granulated, and reused.

Containers can be heat-sealed in a laminated foil pouch package to protect the ampoule, and that packaging equipment can be installed in-line or separate from the BFS machine. The containers also can be packaged with inert gas, such as helium, for automatic leak detection using a helium leak detector.

Documenting Pharmaceutical Development of Biotechnology-Derived Medicinal Products
Labeling, Packaging, and Logistics Labeling and packaging facilities are often congested by the sheer volume of product or bulky packaging materials. Planning is needed to avoid mix-ups of containers, labels, and packaging materials for simultaneous or campaigned operations. Large amounts of particulates are usually found in labeling and packaging areas — such rooms are dirty from staff and material movements — so they must be separate from the processing stream.

Before leaving the shipping dock, products must meet predetermined quality attributes and be properly labeled. FDA has found that 26-32% of all product recalls were due to mislabeling, mostly label mix-ups. Such mix-ups are usually caused by undedicated packaging lines, labels that look alike, and the use of cut labels. If any of these processes are used, extra scrutiny is required.

The packaging and labeling procedure should be simple, logical, and appropriate to the facility layout and the product flow through the labeling and packing area. It helps if a vision machine inspects the labeled product and if packages are color-coded for different sizes and different products and using different labels and visible bar coding. Weight checks on the package line should be used to identify missing inserts or product in the final package.

Accessories. When bulk liquids must be moved in-house, they are often contained in pillow-shaped bags. Dry ice is often used in shipping containers. Platforms are sometimes required to raise containers above the floor to prevent condensation, and interlocking tongue-and-groove lids and bases can retain heat or cold. Time-temperature indicators are needed to alert shippers to adverse conditions the product may have encountered in transit.

Services and supplies needed for shipping and packaging can include insulated shippers, refrigerants, data loggers, time-temperature indicators, package design and environmental testing services, thermal audits of existing shipping and distribution plans, thermal profiling, qualification and validation of new containers, labeling software and supplies, dust-free polyester liners, and clean-room adapted thermal transfer printers with "no-flake, no-smear" ribbons or print.

Regulations. Most of the label regulations are in Title 21, Part 201, of the US Code of Federal Regulations. It states that labels or patient instructions should include (in this order) descriptions, clinical pharmacology, indications and usage, contraindications, warnings, precautions, adverse reactions, drug abuse and dependence information, overdosage details, dosage and administration, and descriptions of how the drug is supplied.

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