Cleanroom production · Batch traceable · Exporting since 2026

Single-use packaging for medicine, biotech and the lab bench.

Fortuna BioPack supplies single-use PE medicine bags, reagent bottles and biomedical laboratory consumables to pharmaceutical, biotech and diagnostic customers across Europe, the United Kingdom and North America — with the documentation and batch traceability your QA department actually asks for.

Built for regulated buyers
Class 8 cleanroom extrusion Lot-level traceability FOB / CIF / DDP shipping Full export documentation
Product range

Four core lines, one supply chain

We keep the range deliberately narrow so that tooling, resin selection and validation stay under control. Everything below is produced to your drawing, your resin and your sterility requirement — not pulled off a catalogue shelf.

Core line

Single-Use PE Medicine Bags

Flexible low-density polyethylene bags for liquid handling, sampling, storage and transfer.

  • Volume0.5 L – 50 L
  • ResinLDPE / LLDPE, virgin, no slip additives
  • FitmentSpout, luer, needle-free, dip tube
  • SterilityGamma 25–40 kGy, or EO on request
See specifications
Core line

Reagent Bottles & Lab Containers

Rigid HDPE, PP and PET containers for reagents, buffers, media and samples.

  • Volume30 mL – 2,000 mL
  • MaterialHDPE, PP, PET, PS
  • ClosureScrew, flip-top, vented, dropper
  • FormatNarrow / wide mouth, square, round
See specifications
Sterile

Sampling & Biohazard Bags

Autoclavable sampling bags and printed biohazard / specimen transport bags.

  • FormatStand-up, flat, zip, with/without wire
  • PrintingUp to 4 colours, biohazard pictogram
  • Temp.−40 °C to 121 °C autoclave
  • ComplianceUN3373 / P650 transport wording
See specifications
OEM

Custom & Private Label

Your artwork, your dimensions, your part numbers — supplied under your own brand.

  • ToolingNew moulds from drawing or sample
  • ArtworkPantone matching, barcode, IFU
  • PackingBulk, cleanroom-bagged, sterile kit
  • Lead timeTypical 25–40 days after approval
See specifications
Why buyers switch to us

The paperwork arrives with the goods

Most sourcing problems are not production problems — they are documentation problems. A container lands in Rotterdam or Savannah and the QA file is incomplete. We treat the dossier as part of the product.

  • Batch-linked documentation. Certificate of analysis, sterility and irradiation certificates, resin lot and material declaration issued against the same lot number printed on the carton.
  • Material compliance package. USP <661> / <87> / <88> statements, EU 10/2011 and FDA 21 CFR 177 food-contact and pharmaceutical-contact documentation for the resins used.
  • Change control. Resin, supplier or process changes are notified in writing before shipment — no silent substitution.
  • One accountable contact. You deal with the same person from first sample to third shipment. Not a ticket queue.
  • Sampling before volume. Pre-production samples and first-article inspection before you commit to a PO.
How we work

From enquiry to container in four steps

Clear gates, written approvals, and no surprises on the invoice.

Specification

You send the drawing, sample or a description of the application. We come back with a written specification, resin proposal and target price — normally inside two working days.

Sampling

Pre-production samples and first-article inspection report. You test them in your own process before anything is tooled at volume.

Order & production

PO confirmed, deposit received, production slot booked. We issue a written production schedule with the shipment date and the documents that will accompany it.

Shipment & dossier

Packing list, invoice, COO, and the full QA file issued against the lot numbers on the cartons. Shipping by sea, air or express to your door.

Quality & compliance

Standards we work to

We are a supplier and exporter, not a converter. Production runs in partner facilities that hold the certifications below, and we carry the evidence through to your file.

ISO 13485

Medical device quality management at the manufacturing sites we source from.

ISO 9001

General quality management, covering order handling and traceability.

USP <661> & Class VI

Biological reactivity and physico-chemical test statements for patient-contact materials.

EU 10/2011 & FDA

Food- and pharmaceutical-contact compliance for the polymer grades we specify.

Gamma & EO sterilisation

Validated 25 kGy and 40 kGy gamma cycles; EO available where the polymer allows.

Export compliance

COO, MSDS, packing declaration and ISPM 15 heat-treated pallets as standard.

Export & logistics

Built around long-distance supply

Our customers are 8,000 km away, so the model is designed for that distance from the start: conservative lead times, shipping-grade packaging, and a single document pack that clears customs without a second round of emails.

  • Shipping-grade export cartons with desiccant and inner poly-liner as required
  • Palletisation to ISPM 15 with heat-treated timber
  • Sea LCL / FCL, air freight, or DDP door delivery — quoted side by side so you can compare landed cost
  • Incoterms 2020: FOB, CIF, CFR, DAP or DDP
  • Third-party inspection (SGS, BV, TÜV) arranged at your request before loading
2 days Typical response to a specification enquiry
25–40 Days production lead time after approval
6+ Document types issued with every shipment
100% Lots traceable to resin batch

Payment terms. New accounts: 30% deposit with the balance against the bill of lading copy, or an irrevocable L/C at sight through a first-class bank. Repeat accounts can be moved to open account terms after three completed shipments.

Send us a drawing, a sample, or just the application

Tell us what the bag or bottle has to do — temperature, chemistry, sterility, volume — and we will come back with a specification and an indicative price. No obligation, no sales sequence.