Bursting Pouches

Q: “We’ve had recent issues with our peel pouches bursting. Can you share why this might be happening and how to correct this issue?”

A: It seems you are stating your “peel pouches [are] bursting” open during sterilization. Based on the limited information from your question (whether the pouch type being used is self-seal or heated seal), for this article, I will address this in a general way. Bursting is the result of inadequate seal strength between the plastic laminate and medical-grade paper, and it is observed after the sterilization process has concluded.

Bursting takes place because of a seal issue or a paper laminate/film issue (e.g., not thick enough). In a medical-grade peel pouch at least two types of seals are made. The other factor is the paper and film strength (how thick it is). Let me address the paper and film strength first, then the sealing issue.

Different manufacturers decide on the thickness of the paper and film they use to make the pouch. The thicker, the better the strength. You will probably pay a little more for a stronger peel pouch. Thus, if you have a strong seal and thin/weak paper/film, the seal will stay intact, but the film or paper might break or burst. Remember, you can compare peel pouches’ paper weight and the film thickness. Just ask the manufacturer for it.

Concerning sealing, bursting takes place at the seal and the paper or film stays intact. Each manufacturer places a seal on two sides of the roll stock at the factory. The user cuts the roll stock to size and seals two sides. In a standard peel pouch, the manufacturer seals three sides and the user seals one side. Each manufacturer decides how many seals and the strength (or bond) of that seal is made between the film and paper. Thus, you need to document where the seal has burst open and correct that issue (user or manufacturer issue).

Medical Device reprocessing departments could make two types of seals:

1. Self-seal chemical bond: To me, this has some issues. You run the risk of creating air channels in the seal; thus, the seal integrity depends on the end-user’s training to seal the pouch properly. The glue or adhesive might also provide a limited-shelf life. Seal integrity quality is hard to control because humans make the seal, and not every person seals the same allowing for variances to occur.
2. Heat seal type pouch (with mechanical bond): This type allows for a better, closer seal (more air-tight) because it is mechanically sealed at a specific temperature, pressure, and dwell time. The seal and the equipment can be verified by specific test methods. Heat sealable pouches usually have a lower unit price (you do need to invest in a heat sealer). Thus, an airtight seal is better than a self-seal because the human factor of sealing is replaced by a verifiable mechanical process.

Based on my observation over the years, I have seen four main reasons why peel pouches could burst during the sterilization process.

• Improper loading of the peel pouches in the sterilizer chamber.
• Peel pouches that are improperly filled with medical devices within the peel pouch.
• Using more than the 3/4-theoretical packaging area (stuffing the pouch).
• Incorrect sealing by your present heat sealer (testing and inspection needed).

The seal strength of both the OEM of the peel pouch and the seal made by the facility is weak; thus, there will be variation/fluctuation in seal strength and porosity.

To help resolve bursting, one must collect data such as a) who packaged the device, b) the type of device, c) which sterilizer was used, d) work shift, e) type of peel pouch, and f) how often bursting is taking place to help understand and to resolve the issue. Let data help solve the issue.

What you might find is you are using a poor-quality peel pouch that has a weak seal and is not that thick in the film and paper laminate area. As I say, “Quality doesn’t cost; it pays,” and you might just need to get a better peel pouch."

Want to know more about sealing and peel pouches? Check out some of my older articles on this subject.^1,2 Watch these videos on what a pouch goes through during the sterilization process³ and how to test your heat sealer properly.⁴

References (APA Style 7th Edition):

1. Kovach, Stephen M. (2023, February 23). Heat sealers: How to test and verify the sealing process. Healthcare Purchasing News. https://www.hpnonline.com/sterile-processing/article/21210664/heat-sealers-how-to-test-and-verify-the-sealing-process

2. Kovach, Stephen M. (2022, October 26). General peel pouch questions. Healthcare Purchasing News. https://www.hpnonline.com/sterile-processing/article/21284722/general-peel-pouch-questions

3. Healthmark Industries. (2022, January 18). What Happens Inside A Sterilizer? [Video]. YouTube. https://www.youtube.com/watch?v=q4Dn8z3-qok

4. Healthmark Industries. (2022, February 8). Heat Sealer Testing in Sterile Processing. [Video]. YouTube. https://www.youtube.com/watch?v=taCPSRJnTe4