Packaging Seal Defects: An Evidence-Based Investigation Checklist

Investigate packaging seal defects by containing suspect product, collecting evidence, testing with agreed methods and changing one variable at a time.

Close-up illustration of a heat-sealed pouch top with a magnifying glass and sample pouches on an inspection bench
Illustration
Short answer

Investigate a seal defect by containing suspect product first, collecting evidence before changing anything, testing with methods agreed in advance, listing candidate causes under Material, Machine, Product and Method, and then changing one variable at a time while recording the result. Settings that work for one film and machine cannot be copied from a general source.

Applies to: Covers heat-sealed flexible packaging on form-fill-seal and flow-wrapping machines. Does not give sealing temperatures, times or pressures, and does not replace the machine manual, the film supplier's data or a site quality procedure.

When a seal fails, the first instinct is often to raise the temperature, slow the machine or increase pressure. Sometimes that works for a shift and then the problem returns, because the real cause was a worn part, a different film batch or product dust in the seal area, and the setting only hid it. Worse, a change made before evidence is collected destroys the information needed to find the cause.

The sequence below is contain, collect evidence, test, list candidate causes, change one variable, record. It names the common defect types, the test methods people agree on and what each one is for, and includes an evidence record you can copy. It gives no sealing temperatures, times or pressures, because those belong to the specific film, machine and product.

Common seal defect types

Figure 1 shows six defect types widely used to describe heat seal problems. Names differ between plants and suppliers, so agree on terms and pictures with your own team and film supplier.

Grid of six seal defect sketches: channel leak, wrinkle or pleat, incomplete or weak seal, overheated or burn-through, product in seal, and misaligned seal.
Figure 1. Six common seal defect types: channel leak, wrinkle / pleat, incomplete (weak) seal, overheated / burn-through, product in seal and misaligned seal. Schematic, not to scale.
Defect type What you see Why it matters
Channel leak A narrow open path through the seal, often at a fold, a gusset or a wrinkle Product can leak and air or moisture can enter
Wrinkle / pleat Folds in the film pressed into the seal Can create a channel or a weak area
Incomplete (weak) seal Seal surface not fully fused, or fused but easy to peel apart The pack may open in handling or distribution
Overheated / burn-through Distorted, thinned, discolored or holed film at the seal Seal may be brittle or perforated
Product in seal Powder, grease, liquid or pieces trapped between the sealing layers Prevents fusion at that spot
Misaligned seal Seal sits off position, over print or crosses a fin or a gusset unevenly Seal area is reduced or the print is damaged

The same visible defect can have several causes, so a defect name is a description, not a diagnosis.

The investigation process

Figure 2 shows the sequence. Each step protects the evidence for the next, so keep the order.

Flow diagram: defect found, contain and quarantine, collect evidence, test by agreed method, candidate causes by material, machine, product and method, change one variable and verify, record and close.
Figure 2. Seal defect investigation flow from defect found to record and close. Schematic, not to scale.

1. Defect found, then contain and quarantine

Stop passing suspect product downstream. Identify how far back the defect could extend, by lot, time and shift, and set aside the packs made since the last known good check. Tag the quarantined product and keep it where it cannot return to the line. What you do with it afterward follows your site’s quality and food-safety procedures, not this guide.

Stopping the machine for the investigation is a decision for the production and quality leads.

2. Collect evidence

Before any adjustment, record the state of the machine, the material and the product:

  • Photos of the defect and of the seal area, with a scale or reference in the picture.
  • Samples: defective packs, and good packs from before and after, kept in a labeled bag.
  • Batch and lot data: product lot, film reel number or film batch, date of manufacture of the film.
  • Machine settings as found, and any alarm history.
  • Time and shift, operator, and what happened just before (a film change, a stop, a restart, a cleaning).
  • Environmental conditions in the area, when relevant, such as nearby open doors or product dust.

Settings as found are easy to lose, so write them down before touching the controls.

3. Test with agreed methods

Choose test methods before you run them, and agree what a pass or fail means with the customer, the film supplier and your own quality team. Each method answers a different question, and none replaces visual inspection of the seal area.

Method What it is used for Notes
Visual inspection Finding wrinkles, product in the seal, misalignment, burn-through and obvious gaps Use consistent lighting and magnification, and compare against agreed defect photos
Dye penetration Showing a leak path in a seal by wicking colored liquid ASTM F1929 is written for porous medical packaging, so it is not a direct fit for other packs; agree on a method for your pack with the people who set your criteria
Bubble test (internal pressurization) Finding gross leaks in a sealed pack placed under liquid while pressurized ASTM F2096 describes a bubble test; it detects gross leaks, not slow permeation
Burst or creep test Measuring how a whole pack resists internal pressure ASTM F1140 covers internal pressurization failure resistance of unrestrained packages
Peel (seal strength) test Measuring the force needed to pull a seal apart ASTM F88 describes a seal strength test method for flexible barrier materials

The table lists what each method does, not what result to expect. Agree the method, specimen preparation and acceptance values in writing. The acceptance values come from your product, shelf-life and customer requirements. Citing a standard without agreeing the conditions invites arguments later.

4. List candidate causes by material, machine, product and method

Once the evidence is in, list possible causes under four headings. Rank them by what the evidence supports, not by habit.

Group Examples to consider Evidence that points here
Material Film batch differences, sealant layer variation, surface contamination, additive migration, reel condition, splice Defect starts at a new reel or batch; certificates differ; samples from other batches seal normally. See film compatibility
Machine Worn or dirty jaws or sealing surfaces, uneven pressure, heater or sensor drift, mis-set jaw alignment, tension or registration problems, timing Defect is in the same place on every pack, begins after maintenance or after a stop, or follows one jaw or one lane
Product Dust, grease or liquid in the seal area, product temperature, product bridging or falling late, particle size or shape changes Defect rate follows a product lot, a fill-rate change or a dosing event; product is visible in the seal
Method Settings changed without a record, changeover not done to procedure, different operators set up differently, inspection frequency or test method inconsistent Defect starts after a changeover or shift change; sheet records differ from settings as found

For machine causes, compare the findings with your maintenance records. The guide on building a site-specific preventive maintenance checklist shows how such tasks are recorded. For method causes, a changeover record often shows which settings were changed and who verified them.

Some seal problems start before the sealing jaws. A film that tracks off center, a bag formed with a fold, or a fin wrinkled by the former may first show up as a seal defect. The film path in flow wrapping and form-fill-seal machines has several places where this can start.

5. Change one variable and verify

Pick the cause the evidence supports most strongly, change one variable only, and run a defined number of packs. Test those packs by the agreed method and compare with the evidence. If the defect remains, return that variable to its original value before testing the next one.

Changing two things at once can make the defect disappear without telling you why, or create a new defect that is hard to link to either change. If the cause is on the supplier side, such as a film batch, give the supplier the evidence package you assembled.

If the line has an inline inspection system, such as the vision systems described in machine vision for packaging inspection, its reject records and images can add to the evidence. They do not replace a test of the seal itself.

6. Record and close

Write down what was found, what was changed, who verified it and what was decided about the quarantined product. Update the setup sheet or procedure if the cause was a method problem, and the maintenance plan if the cause was wear. Close the record only after the verification run has been tested and signed off by the person responsible under your procedure.

Evidence record template

Copy this table into your own quality system. The right-hand column says what to write.

Field What to record
Date, time, shift When the defect was found and by whom
Machine and line Identification, and which jaw, lane or station if known
Product and lot Product code and lot number
Film and batch Film grade, reel number, film batch or certificate reference
Defect type One of the agreed types, with photo reference
Defect location Where on the pack and on the seal; every pack or intermittent
Settings as found Parameters from the machine screen, recorded before any change, with units
Events before the defect Film change, stop, cleaning, changeover, maintenance
Containment Which packs were quarantined, where, and who authorized it
Samples taken Count, labels and storage location
Tests performed Method name, who ran it, date, result for each sample
Candidate causes Material, Machine, Product, Method, with supporting evidence
Change made Single variable, from what to what, and when
Verification result Number of packs run, tests done, result
Decision and sign-off Disposition of quarantined packs, close-out and responsible person

Assumed example. A line starts to produce a channel leak at one corner of the seal. The record shows it began after a new film reel was loaded, and the settings as found match the setup sheet. Retained samples from the previous reel seal normally under the same test method. The material group becomes the leading candidate, and the evidence package, including the reel numbers and test results, goes to the film supplier. The scenario is invented for illustration and is not measured or market data.

Information to request from suppliers

The film supplier can provide the technical data sheet and batch certificate for the lot in question, the sealing window for the sealant layer, and any known issues for that structure.

The machine supplier can provide the sealing section of the manual, how jaw parameters are verified, the wear parts and signs that they need replacing, and the diagnostic data the machine records.

Your own quality team should supply the agreed test methods, acceptance criteria and sampling plan for seals.

Limits and on-site verification

This checklist structures an investigation. It cannot say why a particular seal failed or give a setting that will fix it, because that depends on the film, the machine, the product and the method in use. The test methods named here show what each test is for. The people who own the specification must agree the method, specimen and acceptance value for your pack and confirm them against the standard’s current edition.

The sealing area has hot jaws, moving parts and stored energy. Guarding should come from a risk assessment under a method such as ISO 12100, and qualified personnel should do any intervention after following the site’s lockout and energy isolation procedure. Do not remove guards or defeat interlocks to take samples or adjust settings.

References

  1. ASTM F88/F88M-23 — Standard Test Method for Seal Strength of Flexible Barrier Materials — ASTM International
  2. ASTM F1929-23 — Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration — ASTM International
  3. ASTM F2096-11(2019) — Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) — ASTM International
  4. ASTM F1140/F1140M-13(2025) — Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages — ASTM International
  5. ISO 12100:2010 — Safety of machinery — General principles for design — Risk assessment and risk reduction — ISO

Update history

  • : First published.