Decades of experience in a range of industries
Proven processes for smooth delivery
Engineering and design expertise
Pharma Automation: A Prescription for Advancement
Most people have the general sense that the pharmaceutical industry solely produces medicines, but that’s only one of its many layers. If we slice down the middle of this massive industry, we find many layers that work together to manufacture medicines to the highest standards of quality and care. It’s all made possible in part through pharma automation.
Within pharmaceuticals that are many specializations such as the scientific formulation of new drugs, clinical trials that objectively prove drugs to be safe for wide scale use and component manufacturing. These components include all of the many devices that make, store, deliver or otherwise contact drug products.
Defining Pharmaceutical Device Manufacturing
The devices that are used in the development, production, distribution and administration of drugs can be categorized as pharmaceutical devices. Pharmaceutical devices are not the medicinal products themselves, but are the durable and disposable goods directly associated with those medicines.
Like medicine manufacturing, pharma device manufacturing is just as critical to the overall safety and potency of drug administration, which as we’ll see further below, is why automation is such a large part of any pharma manufacturing discussion.
Automated Pharmaceutical Device Manufacturing Applications
Pharmaceutical devices universally have two things in common: They must be able to achieve sterility so that they do not alter or contaminate the medicines they will contact, and they must pass extreme regulatory scrutiny across every stage of their production.
For these reasons, pharmaceutical devices are typically manufactured in cleanroom environments using automated hygienic process control systems to producing products such as:
Drug Administration
Applicators, utensils, dosing syringes and injection syringes.
Laboratory Components
Such as centrifuge bowls, scale tops, testing instrument probes and sensors, analytical cartridges, test tubes and dishes, and consumable test system parts.
Containers
Like pill bottles, pill bags, dispensers and storage organizers.
Consumables and Disposables
Like IV tubes, fluid bags, disposable applicators such as single-use epinephrine pens, and single-use medicated patches and pouches.
Packaging
Including blister packs, foil bags, punch packs and sleeves that hold medicines, as well as mold inhibitors and moisture absorbers that are placed inside these packages alongside medicines.
Diagnostic Kits
That cover a wide array of pre-packaged testing, sampling, and dosing kits for various diseases and illness treatments.
OEM / MRO Components
The manufacturing equipment that produces all the above types of products. These will themselves need many replacement parts such as plastic welding horns, molding liners, nozzles, contact pads and filter elements.
Manufacturing Technologies for Pharma Automation
Automating Processes
In the United States, pharmaceutical device manufacturing is governed by the federal Food and Drug Administration (FDA), which issues and enforces technical industry standards that all manufacturers must comply with. At the core of these standards are Current Good Manufacturing Practices (cGMPs), which are specific regulations that set minimum requirements for the methods, facilities and controls used in manufacturing, processing and packing of a drug product.
cGMP requirements also extend to pharmaceutical devices, as no drug product can be considered safe if it was not made or handled with devices that also meet the same stringent expectations.
In practice, automated solutions are essential tools that manufacturers employ to meet cGMP requirements such as:
A major part of cGMP requirements centers on a manufacturer’s quality assurance and quality control programs, setting the expectation that quality parameters are established, measured and enforced throughout a manufacturing operation. In turn, pharma automation companies provide software and integrated hardware systems that directly connect and enforce QC parameters at the machine level.
Automated fabrication methods further remove humans and contamination potential from the equation, employing hygienic mechanized tool processes in place of manual operations. For example, AMS’ PJ-401 Plastic Joining System is widely used in pharmaceutical device manufacturing for single or multi-process fabrication needs, offering ultrasonic welding, fusion welding, heat staking, spin welding, spot welding and even textile welding.
Using online instrumentation, real-time process controls, fail-over safety logic, and automated robotics all help remove variables (especially human variables) and mitigate risks from pharmaceutical device manufacturing to ensure patient safety.
Traceability solutions provide complete visibility into a product’s history by storing digital records at key touchpoints through the supply chain. Traceability records are critical to ensure the purity and authenticity of raw materials, as well as in rapidly identifying and isolating potentially suspect products.
Integrated inspection, testing, evaluation and validation systems can further automate final production and quality release steps in a pharmaceutical device manufacturing operation. For example, AMS’ LT-401 Leak Testing System serves many drug container and applicator products by performing all types of quality control leak testing, including pressure decay, vacuum decay, mass spectrometry and bubble test methods.