Pharmaceutical cans · Primary packaging
A 10-litre HDPE can made from 100% virgin resin for pharmaceutical solutions and medical devices. Blow-moulded, inspected and packed in a positive-pressure Class D+ cleanroom, managed to ISO 15378.
ISO 15378
GMP for primary packaging, since 2019
D+
Cleanroom above Class D
ISO 9001
:2015
100%
Virgin resin
Overview
Pharmaceutical packaging is a separate pillar at Thaloplast, with its own building, raw-material store, lines and staff. Cans are blow-moulded and finished in a positive-pressure Class D+ cleanroom, managed to ISO 15378, the GMP standard for primary packaging of medicinal products.
Product
Clean, sealed and traceable to the lot. HDPE body, LDPE inner plug and PP screw cap, all virgin food-contact grade resin.
HDPE · 10 L
Primary packaging for pharmaceutical solutions and medical devices. One-piece handle, two-layer closure (LDPE inner plug and PP screw cap), embossed volume marks and a date clock on the body and base. Every delivery comes with a Certificate of Analysis (COA).
Specifications
Inspection requirements applied to every lot. The release specification (COA) follows each customer’s approved drawing.
≤ 50CFU/can
Total aerobic count of at most 50 CFU per can and endotoxin below 0.5 IU/mL (BET test with 1 litre of water). Cans are blown with oil-free compressed air through a 0.2 µm final filter.
Class D+ cleanroom · Test results
The can blowing room is tested regularly by an independent laboratory. Every particle and microbial result is well below the Class D limit, evidence of the D+ operating standard Thaloplast applies.
Particles ≥ 0.5 µm
Limit 3,520,000 /m³
Highest result
288,393 /m³8% of limit
About one twelfth of the permitted limit.
Particles ≥ 5.0 µm
Limit 29,300 /m³
Highest result
3,361 /m³11% of limit
Almost nine times below the limit.
Airborne microbes
Active sampling · limit 200 CFU/m³
Highest result
4 CFU/m³2% of limit
Near-zero microbes in the blowing room air.
Settle plates, 4 h
Limit 100 CFU/4 h
Highest result
0 CFU/4 h0% of limit
No colonies on the settle plates.
Surface microbes
Conveyor, control panel · limit 50 CFU/plate
Highest result
13 CFU/plate26% of limit
Contact surfaces cleaned and monitored on schedule.
Compressed-air microbes
At point of use · limit 200 CFU/m³
Highest result
1 CFU/m³0.5% of limit
The air blown into the can is close to sterile.
Non-cytotoxic
ISO 10993-5
Highest result
89.25% cell viabilityNational Institute of Drug Quality Control, 2026
At 100% extract concentration, above the 70% acceptance threshold.
Product name, lot number, production and release dates, expiry; tests, methods and limits; measured results; ISO compliance statement; signature of the quality unit.
Kept long term, traceable from the resin lot to the delivered lot.
Particles, airborne and compressed-air microbes measured yearly by an independent body.
Particles measured at rest at 6 points, 50 L sampled per point. Figures are the highest values recorded; 100% of points passed.
Request the quality dossierWhat it means for pharma customers
Independently certified systems, with records ready for every audit.
ISO 15378 combines ISO 9001 with GMP requirements specific to primary packaging.
SMETA meets the ESG criteria of multinational groups.
Own building, store, lines and staff, never shared with the recycled-plastics lines.
Quality control
Every lot passes six control steps. All data goes into the batch record for traceability.
Processes, equipment and software are validated before use in production.
Complete, accurate data, recorded at the time.
Staff are trained regularly on GMP, hygiene and procedures.
| Practice | How Thaloplast applies it | Reference |
|---|---|---|
| Nonconformance management | Detect, isolate and promptly notify the customer of any deviation affecting the product | ISO 15378 |
| Corrective & preventive action (CAPA) | Root-cause analysis, correction and effectiveness follow-up for every complaint or adverse event | ISO 9001 · ISO 15378 |
| Change control | Changes to materials, processes or equipment are assessed, validated and notified to the customer in advance | GMP for primary packaging |
| Batch records & traceability | Complete batch records, kept long term, traceable from resin lot to delivered lot | ISO 15378 |
| Risk management | Identify, assess and control risk across the product life cycle | ISO 14971 |
| Customer audits | Ready for scheduled and unannounced supplier audits | International practice |
Key partner
The 10 L can is supplied under the group’s quality agreement and regular supplier audits, covering the cleanroom, compressed air, batch records and change control.
2 million pharmaceutical cans a year, 100% of lots shipped with a COA.
ISO 15378:2017Primary packaging for medicinal productsCertified by SGS
ISO 9001:2015Quality management systemCertified by Quacert Vietnam
SMETA - SedexEthical trade auditAudited by SGS and IntertekPacking & ordering
Cans are packed in at least 2 new, clean PE bags, free of dust and insects, and stored and shipped apart from other goods.
Packing
2 PE bags
New, clean PE bags, free of dust and insects.
With every delivery
COA
A COA with measured results, signed by the quality unit.
Shelf life on delivery
≥ 2/3
At least two thirds of the shelf life remaining.
Can 10L data, the quality standard, Class D+ cleanroom test results and Thaloplast’s quality system, in one PDF.
No. Pharmaceutical and medical packaging uses virgin resin only.
Yes. Every lot has a detailed batch record for complete traceability.
In a Class D+ cleanroom at our factory in Tien Son Industrial Park, Bac Ninh, managed to ISO 15378 and GMP principles.
Yes. The HDPE body, LDPE inner plug and PP screw cap are all virgin, food-contact grade resin.
A Certificate of Analysis (COA) for every lot, listing tests, methods, limits and measured results, signed by the quality unit. Batch records are kept long term for traceability.
Yes. Send your drawing or technical requirements and Thaloplast replies with a sample plan and quality dossier.
Get started
Send your drawing or technical requirements. Thaloplast replies with a sample plan and quality dossier.
PDF · 12 pages · 5.1 MB
Can 10L data, quality standard, Class D+ cleanroom results, quality system.
Download catalogueTechnical questions, quality documents or sample requests.
Hotline 09123 77696We reply within 1 working day.
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