Module 2 Flashcards
(57 cards)
__________ involves the research, development, creation, and manufacturing of drugs.
Pharmaceutical engineering
Pharmaceutical engineering focuses on _______________
designing, building, and
improving manufacturing facilities that produce drugs. Although some
pharma engineers also work with discovering and formulating drugs.
Pharmaceutical engineers perform the following specific job duties:
- Conceptualizing and designing products
- Synthesizing and testing compounds
- Setting safety and quality protocols
- Measuring potential side effects and stability issues
- Manufacturing products
- Labeling products and ensuring they comply with regulations
- Packaging products to optimize their distribution
____________ sets the standard for how
pharmaceutical engineers should perform their jobs to help minimize the
risks involved with pharmaceutical production.
Good Manufacturing Practice (GMP)
GMP is promulgated by the US Food and Drug Administration under the
authority of the _________. These
regulations, which have the force of law, require that manufacturers,
processors, and packagers of drugs, medical devices, some food, and
blood take proactive steps to ensure that their products are safe, pure, and
effective.
Federal Food, Drug, and Cosmetic Act.
Four Pillars of Pharmaceutical Engineering
API and Biotech
Dosage Form Manufacturing
Fill and Finish
Assembly and Packing
On a basic level, drugs consists of two parts: the _____________ and the chemically inactive _______.
active pharmaceutical
ingredient (API); excipient
Biotech and Biopharmaceuticals involve utilization of _______, but other
systems are utilized for specialized products such as vaccines.
either microbial or mammalian expression systems
Additionally, the industry is facing new challenges,
- Antibody drug conjugates (ADC) for cancer treatment
- New vaccine technologies (vectors and nucleic acid vaccines)
Facilities need to be built in a flexible way to support a broad range of
____________.
manufacturing technologies as well as volume requirements
API & Biotech requirements range from extremely small volumes needed
for _________.
personalized medicine, a few hundred kilos for orphan drugs, and tons of products for common diseases like diabetes, arthritis and cancer
MIT Researchers aimed to create an _______________ for the continuous manufacturing of_______________.
On-Demand Pharmacy; ciprofloxacin
The most common way of delivering an active pharmaceutical ingredient today is through a tablet, which we call an _________.
oral solid dosage (OSD)
Manufacturing facilities for OSD products are still the
most common pharmaceutical manufacturing facilities. However, most of the traditional blockbuster OSD products are now ______________
off-patent.
New OSD products – which are of a higher ______ - are typically for smaller volumes, requiring a high
_______ manufacturing set-up.
potency; flexible
Dosage Form Manufacturing Pressures
- How to make production more cost-effective.
- Innovative delivery platforms (e.g., sustained release, sprays and chewing
gum). - Generic manufacturers increasing production capacity.
- Regulatory requirements and health, safety and environmental standards
evolving through the years.
Fill and Finish: ____________ are very important – the actual filling of the
pharmaceutical product on any dosage form is a highly critical part of the
manufacturing process.
Sterility and correct dosage
A growing trend of small batch sizes is pushing manufacturers to increase
the __________________
level of flexibility of aseptic production..
Levels of flexibility of aseptic production.
- Facilities accommodating multiple products.
- Increase productivity for smaller batches.
- Prevent contamination.
- Minimize number of rejects.
______________ is the process of filling commercially sterilized products into
pre-sterilized containers.
Aseptic filling
The containers are sterilized using one of four techniques:
- Heat: hot air, steam
- Mechanical: water, brushing
- Irradiation: infrared, ultraviolet rays
- Chemical: hydrogen peroxide, chlorine
Although not as critical as product filling, optimized _________ can be a crucial differentiator when it comes to
price.
assembly and
packaging processes
The modern pharmaceutical packaging world prompts challenges that
significantly influence manufacturing costs which may indicate an
increase in _________ which will then impact __________.
stock keeping units; efficiency
modern pharmaceutical packaging world
- Compliance, quality and tracking of products
- Trends of serialization
- Late-stage customization
- Patient-centricity
