Pharmaceutical packaging (or drug packaging) is the packages and the packaging processes for pharmaceutical preparations. It involves all of the operations from production through drug distribution channels to the end consumer.
Pharmaceutical packaging is highly regulated but with some variation in the details, depending on the country of origin or the region. Several common factors can include: assurance of patient safety, assurance of the efficacy of the drug through the intended shelf life, uniformity of the drug through different production lots, thorough documentation of all materials and processes, control of possible migration of packaging components into the drug, control of degradation of the drug by oxygen, moisture, heat, etc., prevention of microbial contamination, sterility, etc. Packaging is often involved in dispensing, dosing, and use of the pharmaceutical product. Communication of proper use and cautionary labels are also regulated. Packaging is an integral part of pharmaceutical product. [1] [2]
Bulk pharmaceuticals can be shipped to another pharmaceutical company for further processing, to a contract packager for forming unit packs, to international customers, etc. Bulk shipments might be in fiber drums (with plastic liners), bulk boxes, corrugated boxes with liners, intermediate bulk containers, and other shipping containers.
Smaller bulk packs can be shipped to pharmacies, particularly compounding pharmacies. The liquids or powders can be measured and put into primary packages.
Shipments to medical professionals could be at hospitals, nursing homes, veterinarians, dentists, etc. These packaged pharmaceuticals are intended to be dispensed and administered by professionally trained and certified personnel.
Drugs under prescription control are sent to pharmacies in multi-packs
of unit packs or in bottles containing many hundreds of capsules.
Typically a pharmacist prepares the final form of the unit pack or
places a lower count of capsules in a small bottle for the customer. In a
pharmacy, pharmacists are available to answer questions and to ensure
that proper documentation is provided. Internet pharmacies mail the
prescribed drugs to the customer; boxes or mailing envelopes are used.
Child resistant packaging is often required on the unit packs; if
requested, a pharmacist is allowed put drugs in a bottle with easy open
features.
Over-the-counter drugs are sold in drug stores, grocery stores, and diverse retail outlets. Usually the package needs to have all the usage information available. Packages often need to have tamper resistant features and child-resistant packaging.
Usually the packaging and labeling of dietary supplements, homeopathic drugs, and folk medicines are not regulated. Some producers voluntarily follow the regulations for over-the-counter drugs or regional Pharmacopoeias.
Formed solid unit doses of pharmaceuticals (capsules, suppositories, tablets,
etc.) are commonly packed in blister packs. In Europe about 85% of
solid unit doses are packed in blister packs with only about 20% in
North America.[4]
Blister packs are pre-formed plastic/paper/foil packaging used for formed solid drugs. The primary component of a blister pack is a cavity or pocket made from a thermoformed plastic. This usually has a backing of paperboard or a lidding seal of aluminum foil or plastic film. Blister packs are useful for protecting drugs against external factors, such as humidity and contamination for extended periods of time.
Blister packing machinery is readily available and is suited to validation processes.[5]
Bottles are commonly used for liquid pharmaceuticals as well as
formed tablets and capsules. Glass is most common for liquids because it
is inert and has excellent barrier properties. Various types of plastic
bottles are used both by drug producers as well as by pharmacists in a
pharmacy.
Prescription bottles have been around since the 19th century.[6] Throughout the 19th and 20th centuries, prescription medication bottles were called medicinal bottles.[6] There are many styles and shapes of prescription bottles.[6]
Prescription bottles come in several different colors, the most common of which being orange or light brown due to its ability to prevent ultraviolet light from degrading the potentially photosensitive contents through photochemical reactions, while still letting enough visible light through for the contents to be easily visible. Other common colors include: Clear (for compounds that don't degrade in light), blue, dark brown, green, and various opaque hues.[7]
Many pharmaceutical products are sensitive to heat or cold. Controlled distribution systems and sometimes cold chains are required.
A mail order or online pharmacy usually ships orders by mail services or by small parcel carrier. The shipment is not temperature-controlled and it may sit in a mail box upon delivery. Conditions can include high or low temperatures outside of the recommended storage conditions for certain products. For example, the USFDA found that the temperature in a steel mailbox painted black could reach 136 °F (58 °C) in full sun while the ambient air temperature was 101 °F (38 °C).[9] Insulated mailing envelopes are sometimes used.
Larger shipments are sent in insulated shipping containers with dry ice or gel packs. A digital Temperature data logger or a time temperature indicator is often enclosed to monitor the temperature inside the container for its entire shipment.
Counterfeit drugs are a serious problem; people can be taking useless
drugs or even very dangerous drugs without knowing it. Custom package
seals, authentication labels, holograms, and security printing, can be valued parts of an entire security system.[10]
They help verify that enclosed drugs are what the package says they
are. Drug counterfeiters, however, often work with package
counterfeiters, some of whom can be sophisticated. No packaging system
is completely secure.
The prescription label usually contains the this information:[11]
Along with the label on the bottle, some pharmacies may provide a "patient information sheet".[11]
This document presents additional patient information and might give
more details, like advising if the patient should take a drug with food
or giving instructions in the case of missing a dose.[11]
The patient information sheet can assist a patient in talking with
their physician by suggesting questions to ask and directing patients to
speak up if they are taking certain other drugs or have certain other
medical conditions.[11]
All aspects of pharmaceutical production, including packaging, are
tightly controlled and have regulatory requirements. Uniformity,
cleanliness, sterility, and other requirements are needed to maintain Good Manufacturing Practices.
Product safety management is vital. A complete Quality Management System must be in place. Validation involves collecting documentary evidence of all aspects of compliance.[13][14] Hazard analysis and critical control points is a methodology which has been proven useful. [15] Quality assurance extends beyond the packaging operations through distribution and cold chain management; Good distribution practice is often a regulatory requirement.
With a large portion of pharmaceutical packaging being outsourced to contract packagers, additional demand is being placed on specialty areas, i.e. specialty dosage forms.[16]
Pharmaceutical packaging is highly regulated but with some variation in the details, depending on the country of origin or the region. Several common factors can include: assurance of patient safety, assurance of the efficacy of the drug through the intended shelf life, uniformity of the drug through different production lots, thorough documentation of all materials and processes, control of possible migration of packaging components into the drug, control of degradation of the drug by oxygen, moisture, heat, etc., prevention of microbial contamination, sterility, etc. Packaging is often involved in dispensing, dosing, and use of the pharmaceutical product. Communication of proper use and cautionary labels are also regulated. Packaging is an integral part of pharmaceutical product. [1] [2]
Contents
Segments of usage
Pharmaceutical packaging can often be thought of by the segment in the distribution system being encountered and by the functions needed by the user of the package. Packaging requirements are different.[3]
Bulk drugs in fiber drums
Smaller bulk packs can be shipped to pharmacies, particularly compounding pharmacies. The liquids or powders can be measured and put into primary packages.
Shipments to medical professionals could be at hospitals, nursing homes, veterinarians, dentists, etc. These packaged pharmaceuticals are intended to be dispensed and administered by professionally trained and certified personnel.
Preparing consumer packaging of prescription drugs at pharmacy
Over-the-counter drugs are sold in drug stores, grocery stores, and diverse retail outlets. Usually the package needs to have all the usage information available. Packages often need to have tamper resistant features and child-resistant packaging.
Usually the packaging and labeling of dietary supplements, homeopathic drugs, and folk medicines are not regulated. Some producers voluntarily follow the regulations for over-the-counter drugs or regional Pharmacopoeias.
Package forms
The wide variety of pharmaceutical solids, liquids, and gasses are packaged in a wide variety of packages. Some of the common primary packages are:Blister packs
Birth control pills in blister packs
Blister packs are pre-formed plastic/paper/foil packaging used for formed solid drugs. The primary component of a blister pack is a cavity or pocket made from a thermoformed plastic. This usually has a backing of paperboard or a lidding seal of aluminum foil or plastic film. Blister packs are useful for protecting drugs against external factors, such as humidity and contamination for extended periods of time.
Blister packing machinery is readily available and is suited to validation processes.[5]
Bottles
A foil innerseal on a bottle
Prescription bottles have been around since the 19th century.[6] Throughout the 19th and 20th centuries, prescription medication bottles were called medicinal bottles.[6] There are many styles and shapes of prescription bottles.[6]
Prescription bottles come in several different colors, the most common of which being orange or light brown due to its ability to prevent ultraviolet light from degrading the potentially photosensitive contents through photochemical reactions, while still letting enough visible light through for the contents to be easily visible. Other common colors include: Clear (for compounds that don't degrade in light), blue, dark brown, green, and various opaque hues.[7]
Timed Dosing
Some mail order pharmacies are now offering timed dosing packets for medications. They put a certain number of pills, as directed by your physician into a plastic package and print the date and time that the drugs are to be taken. It is used for people with multiple medications that are taken at different times of the day. [8]Temperature
Shipment of vaccine: PU insulated box, gel packs, temp monitor, etc.
A mail order or online pharmacy usually ships orders by mail services or by small parcel carrier. The shipment is not temperature-controlled and it may sit in a mail box upon delivery. Conditions can include high or low temperatures outside of the recommended storage conditions for certain products. For example, the USFDA found that the temperature in a steel mailbox painted black could reach 136 °F (58 °C) in full sun while the ambient air temperature was 101 °F (38 °C).[9] Insulated mailing envelopes are sometimes used.
Larger shipments are sent in insulated shipping containers with dry ice or gel packs. A digital Temperature data logger or a time temperature indicator is often enclosed to monitor the temperature inside the container for its entire shipment.
Counterfeiting
Two drug packages appear to be identical in normal light
Selective UV wavelength identifies counterfeit package on left
Prescription labels
Prescription drug packaging often comes with a drug label.[11] Even though drugs come with instructions, it is best for patients to talk with their physician and their pharmacist about using a drug.[12] The patient can then use the label for additional information and for ideas on questions to ask their health care provider.[12]The prescription label usually contains the this information:[11]
- pharmacy name
- name of the physician who wrote the prescription
- brand of the drug
- generic name of the drug
- instructions for taking the drug
- safety alerts
- drug expiration
- patient name
- any identifying number for the prescription
- date the prescription was filled
- dose of the drug
- number of drug refills permitted
Packaging production
Example pharmaceutical packaging line
Product safety management is vital. A complete Quality Management System must be in place. Validation involves collecting documentary evidence of all aspects of compliance.[13][14] Hazard analysis and critical control points is a methodology which has been proven useful. [15] Quality assurance extends beyond the packaging operations through distribution and cold chain management; Good distribution practice is often a regulatory requirement.
With a large portion of pharmaceutical packaging being outsourced to contract packagers, additional demand is being placed on specialty areas, i.e. specialty dosage forms.[16]
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