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On Point Sterile Manufacturing and Aseptic Fill-Finish

The What and Why of Aseptic Manufacturing

Parenteral drugs bypass the body’s natural infection barriers, requiring strict sterility to ensure patient safety and drug stability. Sites for parenteral administration include:
  • Subcutaneous (SC): Under the skin
  • Intramuscular (IM): In a muscle
  • Intravenous (IV): In a vein
  • Intrathecal (IT): Around the spinal cord
Sterile processing ensures parenteral drug products are aseptic and safe—no contamination, no compromises.

There are two main approaches:

  • Terminal Sterilization: After manufacturing, heat, radiation, and/or filtration sterilize the drug product and container/closure. This can be less effective for complex drug products, requiring expert judgment to determine when aseptic manufacturing is necessary.
  • Aseptic Manufacturing Process: End-to-end sterility. The drug product and container/closure are sterilized separately and combined under strict environmental controls, with sterilized equipment and expert oversight at every step.

Download: A Complete Guide to Aseptic Manufacturing

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Why the Right CDMO Matters for Tough Projects

Aseptic fill-finish manufacturing is one of the most demanding processes in drug production, leaving no margin for error. A CDMO can make all the difference. You need a team that thrives on complexity and lives to solve problems.
The right CDMO helps mitigate risks by:
  • Preventing cross-contamination of starting materials, intermediates, and finished products.
  • Using single-use technology for mixing, holding, and storing batches without introducing risks related to extractables and leachables.
  • Using non-destructive testing procedures to evaluate materials without wasting them.
Advancing your project with a CDMO begins with tech transfer. No two tech transfers are alike, and sterile manufacturing and aseptic fill-finish projects present unique challenges that demand specialized expertise. Look for a partner who has:
  • Deep product understanding
  • Aseptic manufacturing process expertise
  • Robust control strategies
  • Rock-solid process validation
  • Unwavering commitment to quality and compliance

Speak the Language of Aseptic Manufacturing

From routes of administration to container types for aseptic fill-finish, here’s the terminology you need to get to grips with the aseptic basics.
Aseptic fill/finish manufacturing processing stages.

Parenteral

Drugs with non-oral routes of administration. Common routes of administration include intramuscular, subcutaneous, and intravenous.

Sterile

Medications used for injections, infusions, or topical eye applications that are completely contaminant-free. Non-sterile medications include suppositories, capsules, and tablets.

Injectable

Sterile drugs administered into the body using a needle and syringe.

Biologics

Composed of living entities, like cells and tissues, or their products, like proteins and nucleic acids. Biologics include vaccines, gene therapies, and recombinant proteins.

Vaccine

Biological preparations that provide active acquired immunity to infectious diseases by mimicking disease-causing microorganisms, often using weakened or inactive forms of the microbe or its proteins.

Syringe

A device used to inject or withdraw fluid from the body, commonly used in parenteral drug administration.

Vial

Small containers, typically glass or plastic, used to store medications as liquids, powders, or capsules.

Cartridge

Intended for multiple uses, cartridge syringes often come in kits that include a pre-filled drug cartridge and a piston syringe with a needle inserted.

Flexibility is Key for Clinical Trial Batches

Aseptic clinical trial manufacturing (CTM) delivers safe, sterile drug batches for clinical studies.
With strict timelines, GMP requirements, and the need to support diverse injectable formulations, reliable fill-finish is critical to trial success.
How We Tackle Complex CTM

Agility Wins in Commercial Aseptic Fill-Finish

Large-scale production can bring unexpected challenges, so you need a partner who is ready to take them on—and win.
Operational processes that deliver adaptability, stability, and consistency ensure safe, high-quality therapies reach patients without disruption.
Get Stability at Scale

Quality is Non-Negotiable

It starts with analytical R&D, where experts develop and validate methods to confirm drug identity, purity, and potency, driving formulation development. Methods must be accurate and reproducible for seamless transfer to quality control labs—laying the groundwork for precise production.
Next, you must maintain quality at scale. Advanced machines make this possible, minimizing human intervention to reduce cross-contamination risk and ensure consistency. Robotic aseptic fill-finish meets the demands of the most complex formulations, including oxygen-sensitive products. Our filling technology includes:
Download our fact sheet for key equipment specs.
Through it all, you need to trust that your product is in safe hands—with a GMP-certified partner who has mastered the regulatory maze. GMP standards dictate meticulous control and documentation of every detail, from air filtration to sterilization time limits, ensuring on-point aseptic product integrity.
Our Quality Assurance

Dedicated Teams Drive Aseptic Success

Let’s Talk Complex Aseptic
Behind every successful aseptic fill-finish manufacturing project is a team of experts who bring technical precision, hands-on experience, and a knack for solving the most complex challenges.
The right CDMO prioritizes your project every time, tackling challenges others avoid with a can-do, will-do mindset.
Dedicated project managers keep these teams on track so you get results on time, every time. They oversee the project from start to finish, keeping you updated—with full transparency so you always know where you stand.
A good project manager anticipates challenges—regulatory, supply chain, or technical—and plans accordingly to ensure success is a given.
Let’s Talk Complex Aseptic
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