How many parts need testing for case fda contact?

Answer: Four: liner base, divider, gasket and handle overmould, covering 36 dm² of the 36.8 dm² total. The latch and the printed wall are filed only.

Is the condition 70 ℃/2 h or 100 ℃/1 h?

Answer: It depends on use. Holding at 70 ℃ takes 70 ℃/2 h, boiling disinfection takes 100 ℃/1 h, and long storage takes 40 ℃/240 h.

How is 10 mg/dm² converted to the whole case?

Answer: By part area. An 18 dm² liner allows 180 mg, which is the ceiling for that plate rather than for the case.

Does a masterbatch change force a retest?

Answer: Yes. A reformulated masterbatch is a material change, so every report touching that colour is repeated, 12 samples over 15 working days.

Case Fda Contact: Case FDA Food Contact Testing

Quick answer: A 45 L food delivery case yields 6 contact surfaces, and only 4 need a report under 21 CFR 177: liner base, divider, gasket and handle overmould.

Six contact surfaces, four reports
Matching materials to 21 CFR 177
Simulants, temperature and time
Overall migration and sensory checks
Four parts tested, two filed
FAQ

1. Six contact surfaces, four reports

A 45 L food delivery case opens into 6 surfaces that may touch food: liner base 18 dm², loose divider 9 dm², gasket 6 dm², handle overmould 3 dm², latch 0.8 dm² and outer print 0 dm², a total of 36.8 dm².

Only 4 reach a report. The test is contact area and mode: the latch stays covered by the liner, and the print sits behind 2.5 mm of wall.

That split sets cost: four reports, 3 samples each, 12 samples, 15 working days. A single whole-case report looks cheaper until the laboratory returns it because two parts map to no subpart.

Surface	Material	Area dm²	Contact	Handling
Liner base	PP	18	Flat, food rests on it	Report
Loose divider	PE	9	Side contact, moves with load	Report
Gasket	EPDM	6	Seals against liner edge	Report
Handle overmould	TPE	3	Presses on liner when folded	Report
Latch	PP	0.8	Covered by the liner	File only
Outer print	Printing ink	0	Outer wall, 2.5 mm away	File only

2. Matching materials to 21 CFR 177

21 CFR 177 is organised by material: olefin polymers in 177.1520, rubber articles in 177.2600, closure gaskets in 177.1210, matched on material plus conditions of use.

Case fda contact sample set with an open black case on white, orange devices and batteries in cut foam

The PP liner and PE divider land in 177.1520, the EPDM gasket and the TPE overmould in 177.2600, and the PP latch in 177.1520.

Once the section is fixed the permitted list is fixed too. 177.1520 sets monomers, additives and extraction limits, so an additive outside that list blocks the report.

Printing ink has no section of its own and usually borrows 175.300 on resinous coatings, and only for inner-wall printing. An outer print is filed with a supplier statement instead.

Materials on one case never share a report. PP and EPDM sit in different sections with different conditions, and a combined submission is split by the laboratory.

3. Simulants, temperature and time

Case fda contact work picks the simulant from the food type: aqueous food takes A, water or 10% ethanol; acidic food takes B, 3% acetic acid; fatty food takes D2, vegetable oil.

Conditions follow the harshest real use: 70 ℃/2 h for hot filling and holding, 100 ℃/1 h for boiling disinfection, 40 ℃/240 h for long storage. Each part gets its own worst case.

The area-to-volume ratio is fixed at 6 dm² per 1 kg of simulant. An 18 dm² liner needs 3 kg, the full 36.8 dm² would need 6.1 kg, so parts travel separately.

Every test runs 3 times and averages, and one run 10% above the limit fails the part outright. Retest clauses belong in the contract.

Food type	Simulant	Condition	Parts
Aqueous, dairy	A, water or 10% ethanol	70 ℃/2 h	Liner, divider
Acidic, pickled	B, 3% acetic acid	70 ℃/2 h	Liner, gasket
Fatty, cooked	D2, vegetable oil	70 ℃/2 h	Liner, divider
Long storage	A, water	40 ℃/240 h	All four
Boiling disinfection	A, water	100 ℃/1 h	Gasket, overmould

4. Overall migration and sensory checks

Overall migration is capped at 10 mg/dm², which allows 180 mg of residue from the 18 dm² liner, 60 mg from the 6 dm² gasket and 30 mg from the 3 dm² overmould.

Case fda contact archive kit in an open black case on grey with grey dividers and egg crate lid foam

The detection limit has to sit below 1 mg/dm². A report quoting a 5 mg/dm² limit means nothing was really tested.

Sensory testing is the second gate: 3 assessors smell and taste at 60 ℃ against a blank, and a clear off-note fails the part whatever the migration figure says.

Both gates must pass. At 8 mg/dm² with an off-note the compound goes back for reformulation, at 3 mg/dm² with a clean result the part passes, and the two results are reported in separate columns.

When migration sits near the ceiling, check the compound first: softening oil and curing residue in the gasket and overmould are the usual source, and one oil change often pulls 8 mg/dm² below 3 mg/dm².

5. Four parts tested, two filed

The liner base, divider, gasket and overmould each get one report. All four can share a shipment, but the samples travel in separate bags with separate labels, or the laboratory treats them as one case.

Reports stay valid for 12 months. Four events force a retest: a change of resin or compound supplier, a masterbatch reformulation, a moulding temperature raised by more than 10 ℃, and a revised section or limit.

The gasket is only 6 dm² of the 36.8 dm², yet it changes supplier most often, so keeping it as its own report protects the other three.

Latch and print stay out of the reports but not out of the file: a material certificate and a formulation statement, both wanted at a customer audit, with 2 spare samples kept for 12 months.

Conclusion

Part decisions in food contact work rest on area, material and conditions of use, not on how the case looks. Of the 36.8 dm² of contact surface, 36 dm² belongs to four parts that need reports, while 0.8 dm² and the printed wall go to the file. All four reports answer the same questions: overall migration at or below 10 mg/dm², and a clean sensory result under the harshest simulant and condition. Most of the compliance cost sits in change control rather than in test fees, since every supplier, masterbatch or moulding temperature change voids a report.

Part	Material	21 CFR section	Condition	Reports
Liner base	PP	177.1520	70 ℃/2 h, A and D2	1
Loose divider	PE	177.1520	70 ℃/2 h, A and D2	1
Gasket	EPDM	177.2600	100 ℃/1 h, B	1
Handle overmould	TPE	177.2600	70 ℃/2 h, A	1

This article discusses container-side specifications and design implications only, and does not cover any handling, loading or use of the contents.