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Overview of the primary & secondary packaging services & commercial contract packaging solutions offered by CDMO, CMO contract packagers
Q1. What are the different types of Pharmaceutical Packaging Services offered in the industry?
Pharmaceutical contract packaging companies provide a range of pharmaceutical packaging services including high volume commercial packaging solutions for the primary and secondary packaging types outlined below, as well as support services through the life cycle of drug products.
Packaging is an essential part of the pharmaceutical supply chain as it is a means of presenting, promoting, identifying, informing, complying, and stabilizing drug products and further serves to protect them for distribution, storage, sale, and finally, consumption.
While customized packaging services may differ from company to company or across countries, they are united by their shared goals of assuring patient safety & efficacy of the drug product through its 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 & degradation of the drug, sterility, etc. Conventionally, the pharmaceutical packaging industry is divided into three sections namely: primary packaging, secondary packaging, and tertiary packaging.
Contract packagers offer a suite of pharmaceutical packaging standard services including:
- Capsule & tablet blister packaging
- Strip packaging
- Bottling
- Organic encapsulation
- Shrink-wrapping
- Collating
- Clam shell packaging
- Pouch packaging
- Flow wrapping
- Serialization drive contract packaging services
- Repackaging
- Heat sealing
- Cartoning
- Cold chain capabilities
- Stability packaging
- Pharmaceutical serialization & aggregation
- Label designing
- Kitting
- Bundling
- Bagging
- Printing
- GMP compliance
Q2. What is the difference between primary and secondary packaging?
Primary Packaging
Primary medical packaging, also referred to as sales, retail or consumer packaging, is the material that is in direct contact with drug products. Therefore, it is necessary to know the possible interactions between the primary pharmaceutical packaging containers and their respective contents.
Normally, drug product stability and compatibility are confirmed, which make sure that the custom pharmaceutical packaging is inert and does not alter the chemical composition of the drug, during the primary research and development stage. The main purpose of primary innovative packaging solutions are to protect and/or preserve, contain, and inform the consumer about the drug products they contain.
When it comes to primary pharma packaging solutions, they should emphasize both utility and appearance as it is a key place to place one's logo, slogan, and other information that will help identify and distinguish one brand from another.
Primary pharma packaging solutions maintain the sterility of drug products keeping them fresh for longer, prevents them from breakage/ wear-and-tear, permits serialization & aseptic presentation of the packaged contents, makes shipping easier, and provides a selection of materials to choose from.
On the flip side, the disadvantages of primary pharmaceutical packaging services include difficulty in recycling, poor durability of some materials, and increases in shipping costs as well as consumer prices.
Some of the most common primary pharmaceutical contract packaging types are:
1. Ampoules
2. Vials
3. Blister Packs
4. Bottles
5. Sachets
6. Strip Packs
7. Syringes
Secondary Pharmaceutical Contract Packaging Services
The next level of pharmaceutical packaging is called secondary packaging. Secondary pharmaceutical contract packaging services provide the packaging that holds together the individual units of a good (primary packaged goods), often grouping them into multipacked units.
It is not designed to hold the drugs (that is the job of the primary pharmaceutical packaging standard services), so much as to deliver mass quantities of them to the point of sale or end user. As a result, secondary custom pharmaceutical packages may be removed from items without changing their qualities or attributes.
Typically, the level of packaging a consumer will see first is the secondary pharmaceutical contract packaging; this makes the appearance of secondary packages very important, so much so that designing and branding secondary pharmaceutical packaging can increase product sales.
The main function of secondary pharmaceutical packaging is for branding display and logistics as well as protecting and collating individual units during storage and it is therefore also referred to as grouped or display packaging.
Secondary contract packaging services are important for several reasons, including physical and barrier protection, ease of transport, secondary containment, adherence to regulations, and safety to the patient. Disadvantages include increase in retail price and production footprint, tendencies to get deformed, and decelerating time to market.
Types of secondary packages include, but are not limited to:
1. Cartons
2. Boxes
3. Trays
4. Bundles
5. Wraps
6. Pouches
Q3. What are the different materials used for Pharmaceutical Packaging?
Primary and secondary packaging serve different purposes and therefore the materials used for preparing them are discrete and unalike:
Primary packaging
1. Glass - commercial packaging solutions: Allows inspection of container contents and is available in a wide array of shapes. However, it is expensive as compared to plastic and can be fragile to handle. Ampoules and vials containing fluids for injections and bottles usually come in glass containers.
2. Plastic - innovative packaging solutions: It is flexible, lightweight, cheap and cannot be broken easily. However, they are not as chemically inert and impermeable to gasses and vapors as glass containers. Plastic is generally used for pill/tablet bottles, squeezable bottles for eye drops and nasal sprays, and flexible tubes.
3. Metal - pharma packaging solutions: Used solely in the packaging of non-parenteral drugs (not orally ingested). It is strong, opaque, ideal for pressurized containers, impermeable to moisture, gases, odors, light, etc. Disadvantages include corrosion, concealment of container contents, increased weight, and rigidity, etc. They are commonly used for manufacturing cans, aerosols, screw caps, strip & blisters packs.
Secondary packaging- Fibrous Materials:
1. Cardboard
2. Paper
3. Corrugated fiberboard
The applications and advantages of using fibrous materials in secondary medical packaging are that they increase the area for display, provide better stacking options, provide physical protection to primary packaged items, assemble leaflets, and outers (either as solid or corrugated boards) that aid in bulk shipment. Cartons, bags, labels, trays, boards, etc. are all constructed from fibrous materials, however, plastic may also be used for producing secondary custom pharmaceutical packaged goods.
Q4. What range of contract commercial packaging solutions can one expect from a pharmaceutical packaging service company?
The breadth of specialized pharmaceutical packaging services offered by contract packagers, from early-stage drug form and medical packaging design to managing a product through its life cycle, has expanded year over year. Contract commercial pharmaceutical packaging service providers offer a range of innovative packaging solutions including, but not limited to:
1. Coding and serialization: During serialization, each saleable unit of a prescription drug product, at the primary custom pharmaceutical packaging level, is assigned a unique serial number or code linked to information about the product's origin, batch number, and expiration date. Tracking counterfeit products, providing regulatory compliance, branding & consumer protection, and tracing capability throughout the pharmaceutical supply chain is enabled via serialization drive contract packaging services.
2. Aggregation: Secondary packaged assemblies undergo pharmaceutical aggregation-serialization. While serialization in itself adds a unique identifier to each product at an individual level, an aggregation solution adds codes to the outside of secondary medical packaging all the way up to cases and pallets. Serialization is compulsory, but aggregation is being increasingly implemented on a voluntary basis as it makes the distribution chain as well as stock level management more efficient.
3. Labelling: Within a complex regulatory landscape, sophisticated label solutions can play an important role in supporting product and patient safety. Initially, the label serves to mark the pharmaceutical packaging clearly and reliably by providing information on the product, its administration, and batch number. However, dosage forms and drug delivery methods can vary widely, so the label design has to be optimally tailored to meet the specific requirements of the medication.
4. Quality control: Medical packaging companies often offer cutting-edge technologies to ensure that the customers exact custom pharmaceutical packaging needs are met. The specification and requirement of quality testing depends on the type of pharmaceutical materials used. Containers are tested by many methods, adhering to specifications outlined by regulatory agencies including the USFDA, GMP, WHO, etc.
Temperature controlled pharmaceutical packaging services, blow fill seal (BFS) customized packaging services, secondary pharmaceutical contract packaging services, plasma impulse chemical vapor deposition (PICVD) coating technology, and cold chain capabilities are a few more contract commercial pharmaceutical packaging services that serve as solutions in the contract packaging services industry.
Q5. What evolution has the pharmaceutical packaging service industry witnessed recently with regard to new technologies?
The customized packaging services industry is constantly changing with new compliance measures, customer demands for innovative packaging solutions, anti-counterfeit technologies, etc. and CDMOs offering these pharmaceutical contract packaging services are evolving, with advanced packaging technologies and improvised techniques, to meet their partners’ custom pharmaceutical packaging needs.
A report published by the Association for Packaging and Processing Technologies details that not only are pharmaceutical contract packaging companies scrambling to meet looming serialisation deadlines, they’re also being asked to manufacture more products for less money without sacrificing quality, and are being tasked to come up with innovative technologies and solutions for the pharmaceuticals of the future.
Furthermore, technologies to deal with the counterfeit medication market are gaining traction. Among the more advanced and affordable are developments in perennial encryption technology which effectively prevent the cloning, duplication, and replication of data.
Moreover, the advent of distributed ledger technology, better known as blockchain, has significantly increased the digitization opportunities for customized packaging service providers, with the ability to have a cross-company immutable log of transactions that is not governed by any one organization.
There are numerous other commercial packaging solutions and strategies internalized by primary & secondary packaging companies to become more efficient at offering contract packaging services to their customers. As time goes on, this trend will continue, and pharmaceutical packaging service providers will adapt to and evolve with the market.
Three pharma packaging solutions being increasingly adopted by pharmaceutical packaging standard service providers are:
1. Self injections made safer and easier by reinventing prefillable syringes and shifting towards anti-slip grips.
2. Adopting integrated loudspeakers to customize patient-specific medication instructions and eliminate lengthy package inserts and tiny print.
3. Moving towards smart commercial packaging solutions by using QR codes, holograms, and even chips as well as using temperature-sensitive printing inks that change color if a medication is stored at the wrong temperature.
Q6. What are the key factors influencing the pharmaceutical packaging industry and what are the opportunities available in the future?
Anti-counterfeit measures, patient safety adaptations, innovative pharma packaging solutions & technology use, and quality assurance techniques are some of the key factors affecting the contract commercial pharmaceutical packaging service industry in today's day and age.
In the future pharmaceutical serialization & aggregation, digitization of data via new technologies, and smart packaging solutions are going to become advanced enough to attempt bringing the largest fraud market, counterfeit medications, to a halt. Patient safety adaptations such as child proof pharmaceutical packaging standard services and senior friendly pharmaceutical contract packaging services will continuously advance and be perfected.
Innovative eco-friendly technologies are going to become widespread in the pharma contract packaging service industry in both the primary & secondary packaging sectors, so as to minimize the environmental damage and plastic waste generation via 3D printing and postponement - late stage customization techniques. Temperature sensitive pharmaceutical contract packaging services, new sealing strategies, patient specific packaging technologies, etc. will surface for quality assurance.
Despite this ever-changing landscape, a new Allied Market Research (AMR) report forecasts the pharmaceutical packaging market to reach $104,882 million by 2022, rising at a compound annual growth rate of 6.3% from 2016 to 2022. North America is expected to hold the largest share in the pharmaceutical packaging market due to the growing demand for lightweight and easily transportable packaging.
Additionally, the stringent government regulations for pharmaceutical packaging and demand for sustainable packaging solutions in Asia-Pacific and Europe are some of the factors that are expected to drive the pharmaceutical packaging market during the forecast period. It is important that the industry continues to drive these developments forward to fully realize the potential of the contract packaging services industry.
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