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In a product’s development lifecycle, the importance of packaging can sometimes be overlooked until a packaging specialist becomes involved and can elucidate whether the packaging design is suitable and meets the tests for form, fit and function. Some companies that may not understand or emphasize the critical elements of a good package in the design phase may find out too late that the package is unsuitable after sustaining one or more failures during validation testing.
Once company experts have established the right packaging around the product configuration, then it must adhere to the design requirements. This is where preliminary testing through design of experiments (DOEs) or packaging engineering studies comes in.
Several items need to be considered before package testing can begin such as sample size, test method(s), acceptance criteria, dunnage[1] material or product, use of controls, thermal conditioning (hot and/or cold), transportation simulation testing and cost to name a few. What combination of variables you choose in a packaging test validation procedure can be based on a properly done risk assessment. So to arrive at that perfect combination is just the beginning.
So what if your packaging fails to perform as expected? Just because you had a test failure does not automatically mean that the packaging is inadequate. It does, however, demand evaluation and adjustments. A great place to start investigating a packaging failure is with the four most common failure points encountered in sterile barrier packaging validations.
[1] Dunnage was originally defined as loose materials used to support and protect cargo in a ship’s hold. That was when shipping vessels were the only form of international shipping. In the packaging industry it is material that provides padding in a shipping container that may or may not be representative of .
In aseptic pharmaceutical manufacturing, the packaging for parenteral packaging components is essential for ensuring proper sterilization and utilization. The importance cannot be overstated. Ineffective component packaging can potentially affect patient safety, and result in significant financial loss. Acknowledging this, West conducts exhaustive testing on its packaging systems to ensure that quality and functionality requirements are achieved.
<br />In 2016, the China Federal Drug Administration (CFDA) made two announcements regarding packaging of parenteral drug products. Per these announcements, stability studies of packaging materials should refer to protection, compatibility, safety and functionality properties.
The Japanese Pharmacopeia (JP) has updated chapter 7.03 “Test for Rubber Closures for Aqueous Infusions” and the last date to transition to the new version is <strong>September 30, 2015</strong>.
Traditionally, drugs and biologics have been sold in vials. Utilizing a vial system requires the use of a syringe or other transfer device to withdraw the medication from the vial and facilitate delivery directly to the patient or to an IV bag for subsequent administration to the patient. These steps can result in errors, spills, contamination, or other mishaps. A simplified approach for administration has been to package the drug or biologic as a <a href="/blog/2022/january/importance-of-prefilled-syringe-packaging-in-market">pre-filled syringe</a> combination product. Drug administration is then made easier because the syringe is both the containment system and the delivery system such that the drug can be directly injected into a patient or into an IV bag port.
It has been over a year since China Food and Drug Administration (CFDA) announced <em>Matters Concerning Bundling Review and Approval of Pharmaceutical Packaging Materials, Pharmaceutical Excipients and Drugs</em> (Document No.134 [2016]). As a result, the China pharmaceutical packaging industry is experiencing a revolution.
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