Secondary Packaging for Pharmaceuticals
Secondary packaging components are identified by the FDA as serving one or more of the following functions:
- provide protection from excessive transmission of moisture or solvents into or out of the packaging system.
- provide protection from excessive transmission of reactive gases (atmospheric oxygen, inert headspace filler as, or other organic vapors) into or out of the packaging system.
- provide light protection for the packaging system.
- provide protection for a packaging system that is flexible or needs extra protection from rough handling.
- provide an additional measure of microbiological protection (e.g., by maintain sterility or by protecting the packaging system from microbial intrusion)
Since secondary packaging components are not intended to make contact with the dosage form of the product, they are regulated somewhat differently than primary container closure components. In a new drug application, emphasis is typically placed on the primary components. If the secondary packaging component is specifically intended to provide extra safety measures to the product, such as safety device attached to a syringe, complete information about the packaging material should be provided, including proof that packaging material is quite permeable, such as low density polyethylene (LDPE), the packaging could be considered a potential source of contamination. Permeable packaging materials, in some cases, can facilitate migration of ink or adhesive materials, which can harm the product.
Overwrapping and Flow Wrapping
- Also known as “fin seal wrapping”, “fin sealing”, “cello wrapping” or even “flow wrapping”.
- The process uses an oriented polypropylene film, commonly referred to as cellophane. Items are packaged in high speed runs that can exceed 200 pieces per minute. To maximize output, state of the art horizontal pouch packaging machines are utilized.
- Machines uses conveyors to keep pace with product feeding, which can be done manually, automatically, or through a semi-automatic approach. Individual items are first wrapped in propylene film, and then a fin-seal is created to run along the length of each package. The packaging material is of a tubular orientation, so once each item is secured within the cellophane tube, it must be cut to length, before an end-seal is created.
- The resulting package leaves each item loosely encased in its own tamper resistant enclosure. Where appropriate, hang holes can be added to fin-seal pouches to increase retail display flexibility.
- Flow-wrapping is cost-effective since the process employs high-speed technology that is designed for high-quantity output.
- Pouch material can be clear or opaque, and can be custom printed or left unadorned. In addition to cello-wrapping, fin sealing is appropriate for use with some styles of foil packaging materials.
- Additional barriers can be incorporated into fin-seal packages to address moisture and vapor control requirements.
- Horizontal pouch packaging solutions are available to suit a wide range of contents. Irregularly shaped items and products with sharp corners benefit from additional protection provided by thicker gauge materials.
- Cartoning machines are packaging systems which erect, close and/or erect, fill and close carton blanks or folded and side seams sealed cartons.
- Cartons can come in the form of blanks, which are flat, pre-printed and cut to size and shape, with slots and tabs pre-cut if necessary. These are then folded or ‘erected’ to form the carton in the machine.
- Cartons are made from carton-board which is a semi-flexible paper material with 250 µ to 1000µ in thickness.
- Cartons can come in a wide variety of shapes including hinged lids, triangular, hexagonal, octagonal, double-wall, wave-shaped cartons, and tapered trays.
- Cartoning machine can be semi-automatic machines which close the flaps of manually erected and filled cartons at low speeds, but some more sophisticated machines incorporates pick-and-place product loading or stacking devices, leaflet inserters and coding devices and run at several hundred cartons a minute.
- Modern cartoning machine have benefited from the introduction of subassemblies, programmable logic controllers and even computers which allow the machines to change the size automatically and synchronized using software rather than mechanical transmission components.
- The cleaning of the process machines will be mainly carried out by CIP (Clean in Place) systems. Depending on the sensitivity of the product being produced, the equipment may be cleaned aseptically and therefore eliminating any possible contamination from outside.
- Sterilizing machines can be also called, autoclaves and retorts. There are three main types of sterilizing machines; static, rotary and pilot or laboratory systems.
- General characteristics of cleaning machines are:
- Steam-water spray mix.
- Top shower for cans and glass jars and side shower for pouches and trays.
- Indirect cooling system by heat exchanger allows water recovery.
- All vessel, pipe work and valves and heat exchanger in stainless steel materials.
- Insulated shell with mirror polished stainless steel cladding.
- PLC control with modern connection allows remote troubleshooting and servicing.
- Process monitoring in the operator interface with complete information of temperature, pressure, time and flow.
- Easy product recipe setup with password protected areas.
- Optimum heat distribution (+/- 0.5°C)
- Accurate pressure control ((+/- 0.05 bar)
- The rotary machines will use inverter drives for accurate control during the sterilizing process. Equipment such as basket trolleys and automatic loading systems to fully automate the sterilizing process of products can also be associated.
Coding and Marking
- Machines which apply a code (including bar codes), dates and other variables o unique information to a package or transit container. There are two basic methods: contact or non-contact; and programmable and non-programmable.
- There is a whole range of machines and equipment carrying out these functions, from simple mechanical stamps or overprinters to sophisticated ink jet and laser coders applying computer generated data. These machines are usually attached to a larger packaging machine such as cartoning machine, filler or wrapper.
- Modern ink jet and laser coders can be programmed to carry a large amount of variable information such as lot number, date code; sequential coding based on a unique serial number which is recorded in a secure database. A range of styles, typefaces and characters sizes can be uses and changed easily especially in comparison with older mechanical devices.
- Sophisticated software means coders can be programmed to create a different mark for every product to create a track-and-trace feature on a pack. This helps to prevent counterfeiting. Track-and-trace features can also be used to ease product recall, monitor product quality and track products internally. Examples include sequential or non-sequential codes, a covert code or a machine-readable code.
Conveyors and Conveying Machine
- Conveyors are machines and equipment which carry ingredients, products, containers, packs or packaging components from one place to another.
- There are a large number of different types of conveyor, designed to convey different types of product or to perform particular tasks. They can be divided into four main groups:
- Conveyors for bulk products e.g. powders or free flowing solids
- Conveyors for both bulk products and small unit loads
- Conveyors for small unit loads e.g. bottles or cartons
- Conveyors for large unit loads e.g. pallets or kegs
- In their simplest form conveyors are mechanical assemblies which can be demountable and easy to move. In their most sophisticated form conveyors can be complex machines with drives, controls and sensors. In this form they undertake complex tasks or those needing highly accurate sorting, ordering or distribution of the items or products being conveyed.
- Common forms of belt and slat band conveyors are used for all types of semi-automated or automated processing and packaging functions. They facilitate different requirements during production, and enable different products and packaging functions to be handled.
- Some machines, such as large bakery ovens, include conveyors as part of the process, while high speed wrapping machines require in-feed and out-feed conveyors to be built in to operate at the speeds required.
- Different consistencies of products, (soft, delicate, sticky, hot, chilled, frozen), require different handling techniques and so different designs of conveyor.
- The ability to clean conveyors is an important requirement particularly in food or pharmaceutical plants where rigorous clean-in-place and wash-in-place regimes exist. These conveyors are often made of wire mesh, plastic mesh or stainless-steel and some can be dismantled or moved for ease of cleaning.
Labelling and Labelling Equipment
- Labelling Machines apply labels and decoration onto all types of packaging containers, display, point-of-sale and transit packs.
- Labels are used on every kind of product to brand, decorate or provide information for the consumer. Many labels do all three functions and can contain, for example, pre-printed bar codes supplying, batch, stock and price information to the retailer and consumer.
- Other machines provide print on demand and weigh/price labels, usually for fresh or perishable products where the weight of item varies from pack to pack or for transit purposes. Many of these labels are printed and applied in the store or warehouse.
- Labels are also used to provide protection against tampering (tamper evident) to ensure the product reaches the consumer without interference and unopened. Sleevers or sleeving equipment that apply a sleeve of thermoformable or stretch material to the neck or body of the container, are generally used to apply tamper evident labels. Shrink sleeve labels are also used on products which do not have surfaces suitable for a conventional label.
Pallets and Pallet Loading
- Pallet Forming, Dismantling and Securing machines are packaging machines that assemble or dismantle pallet loads of products, groups of packages or rigid containers on a pallet, with little or no manual intervention, and secure the load on the pallet for security and stability during transportation.
- A recent application for this type of machinery has been to form the retail-ready pallets, mini-pallets and dollies which supermarkets are now demanding for fast-moving product lines not only to minimize the use of transit packing materials but also reduce the amount of labour needed in store to prepare products ready for sale.
Reference:Processing and Packaging Machinery Association