Sterile vs. Pyrogen-Free


The Difference


Sterile vs. Pyrogen-free: What's the difference and why should I care?

Sterile vs. pyrogen-free – it's important to your work and you need to know the difference. First of all, what is a pyrogen? Simply, a pyrogen is any substance that causes a fever. The most commonly thought of pyrogens are bacterial endotoxins and exotoxins, although the host body (human or animal) can also produce pyrogens. The most commonly assayed for pyrogen is lipopolysaccharide, or LPS. It is a component of the bacterial wall of Gram-negative bacteria and is released upon breakdown of the cell wall or bacterial cell lysis.

So, if something has been sterilized, it should be pyrogen-free right? Wrong!

Sterility ensures the absence of viable living bacteria. However, the act of sterilizing a contaminated vial can actually result in the release and deposit of pyrogens, as sterilization destroys bacteria, leading to bacterial cell lysis and release of LPS or other endotoxins and exotoxins.

WHEATON pyrogen-free products are manufactured in settings that prevent the deposition of bacteria and other agents on the products. Sterile products undergo a separate sterilization process dependent on the product and/or end-users' needs. Thus, specific items may be sterile, sterile and pyrogen-free, or pyrogen-free but not sterile.

Thus, it's important to consider your specific needs in order to ensure that your needs are met by your product of choice.

Key Points:

1. Sterile does not mean pyrogen-free.
2. Manufacturing that takes into account pyrogen-free environments are best.

Critical Cleaning

We use USP or WFI purified water, HEPA filtering and package items in certified class 100/10 cleanrooms to remove trace organics, trace inorganics, volatile organics and organic carbon residues.

WHEATON can deliver glass containers and accessories with endotoxin levels of less than 0.06 EU/mL with full documentation and certification, and we can provide a special Type I glass vial with a special additive that will prevent the glass from turning brown when gamma radiated.

  • Low particulate cleaning
  • Depyrogenation, which reduces endotoxin content
  • Chemical cleaning for trace analysis
  • Sterilization (E-beam and gamma irradiation, autoclaving, dry heat)
  • Water for Injection (WFI) rinse (or cleaning)
  • USP Purified Water Rinse
  • Total Organic Carbon (TOC) Process
  • Class 1000: Container and closure without washing treatment
  • Class 2000: Container and closure cleaned and assembled
  • Class 3000: Container and closure cleaned, assembled and quality assurance analyzed

List of Certifications Available

  • Certificate of Analysis, TOC
  • Certificate of Analysis, Endotoxin
  • Certificate of Analysis, Particles
  • Certificate of Process
  • Certificate of Sterility / USP
  • Certification of Compliance
  • Selected Testing by USP Methods
  • Materials Certification

Custom Packaging Configurations

  • Individual or multi-unit clean room bags
  • Single or double bagged
  • Autoclaved bagging in clean room bags (closures only)
  • Autoclaved bagging (single, double or triple bagged)
  • Anti-static tray pack with shrink-wrap

In order to provide you the best service possible, contact WHEATON early in the process to see what steps we can remove from your process to save you valuable time and money.