B26-0096

Fail Quarantine

SAK-CZM18, SAK-CZM 18 · Ca/Zn one pack, medical film. 1,471 kg made on 19 Jan 2026 against WO-2026-0096, 1,471 kg still on the floor, best before 19 Jan 2028.

View certificate of analysis

The run, pallet by pallet

2 pallets off WO-2026-0096. A hold is recorded against the pallet, so the rest of the run stays sellable.

Nothing selected

Released

0 kg

Held

1,471 kg

Despatched

0 kg

Pallets

2 of 2 held

1 2

	#	Pallet label	kg	Status	Location	Note
	1	B26-0096-P01	840	Held	Quarantine bay	Batch rejected at release
	2	B26-0096-P02	631	Held	Quarantine bay	Batch rejected at release

← Backward trace

Every raw material lot consumed into this batch, and the supplier it came from. If a supplier recalls a lot, this is the list of batches it touched.

Raw material	Supplier lot	Supplier	kg
RM-5040 Calcium stearate, bought-in, blending grade	FAC-2407406	Faci Asia Pacific Pte Ltd	363
RM-3050 Epoxidised soybean oil, ESBO	CHE-2404293	Chemiplas Australia Pty Ltd	267
RM-2024 Zinc oxide, pharmaceutical grade	IMC-2611105	IMCD Australia Ltd	156
RM-3016 Zeolite 4A, low sodium, pharma	SIN-2404688	Sinochem Plastics Co. Ltd	123
RM-3060 Glycerol monostearate, GMS 40	PGR-2405517	Peter Greven GmbH & Co. KG	132
RM-6010 Calcium carbonate, precipitated, coated	OMY-2408925	Omya Australia Pty Ltd	144
RM-3040 Pentaerythritol, mono, 98%	SIN-2612674	Sinochem Plastics Co. Ltd	69
RM-4010 Phenolic antioxidant 1010, bulk	SON-2406883	Songwon Industrial Co. Ltd	24
Charged into the batch			1,278 kg

Forward trace →

Every despatch this batch went out on. If a customer raises a complaint against a batch number, this is who else received it.

Nothing shipped: the batch failed release and is segregated in Quarantine.

Release record · Pharmacopoeial release

Tested 20 Jan 2026 by Vinh Le. Full monograph assay with retained sample. Certificate of analysis issued with every despatch.

Fail

Yield 99.03 % 97.5-100

Assay 101.99 % 98-101.5

Heavy metals 1.6 ppm 0-10

Moisture 0.68 % 0-1.5

Metal content 6.81 % 6.2-7.4

Appearance vs standard Pass visual

Sieve residue 75 µm 0.17 % 0-0.5

Out of specification. Batch transferred to Quarantine pending a rework or concession decision.

SUNACE

Australia · Leading through quality

Sun Ace Australia Pty Ltd
32-38 Remington Drive, Dandenong South VIC 3175
ABN 52 006 388 102 · +61 3 9702 9444 · sunace@sunace.com.au

Certificate of analysis

B26-0096

Grade: SAK-CZM18
Manufactured: 19 Jan 2026
Best before: 19 Jan 2028
Quantity: 1,471 kg

Sun Ace Australia Pty Ltd certifies that batch B26-0096 of SAK-CZM18, SAK-CZM 18 · Ca/Zn one pack, medical film, was manufactured at Dandenong South under our ISO 9001:2015 quality system and tested against quality plan QP-PHARMA (Pharmacopoeial release) with the following results.

Test	Result	Specification	Method
Yield	99.03 %	97.5-100 %	SA-QC-YIEL
Assay	101.99 %	98-101.5 %	SA-QC-ASSA
Heavy metals	1.6 ppm	0-10 ppm	SA-QC-HEAV
Moisture	0.68 %	0-1.5 %	SA-QC-MOIS
Metal content	6.81 %	6.2-7.4 %	SA-QC-META
Appearance vs standard	Pass	Pass	SA-QC-APPE
Sieve residue 75 µm	0.17 %	0-0.5 %	SA-QC-SIEV

Metallic stearate grades are produced from vegetable-based fatty acids and are declared free of animal substances and BSE free. A retained sample is held for 24 months from the date of manufacture. Handle in accordance with the current safety data sheet.

Released by Vinh Le

Date