Cleanroom standards
Sterile filling and packaging operations take place in an ISO 14644-1 Class 7 cleanroom (≤352,000 particles ≥0.5μm per cubic meter, equivalent to US FED-STD-209E Class 10,000). The cleanroom is monitored continuously for particle count, temperature, humidity, and differential pressure.
Material standards
- Borosilicate glass: USP <660> Type I, conforming to international pharmacopoeia requirements for primary container materials. Low extractables, high chemical inertness.
- Polypropylene tubes: Medical-grade virgin resin, certified BPA-free and DEHP-free, USP Class VI compliant.
- Caps and closures: PTFE-lined screw caps or butyl rubber stoppers with aluminum crimp seals. Cap liners meet USP <381> elastomeric closure requirements.
- Diluent solutions: Sterile water-for-injection (WFI) grade with 0.9% benzyl alcohol preservative. Endotoxin levels below 0.25 EU/mL.
Sterilization methods
- Gamma irradiation: Plastic centrifuge tubes, petri dishes, and sample collection tubes receive 25 kGy gamma irradiation, validated to achieve a Sterility Assurance Level (SAL) of 10⁻⁶.
- Cleanroom filling: Glass vials and diluent ampoules are filled and capped in ISO Class 7 conditions, with each fill batch quality-tested against USP <71> sterility specifications.
- Autoclave validation: Reusable lab equipment is supplied with autoclave-compatible certification (where applicable).
Quality control workflow
- Incoming material inspection: Every raw material batch (glass, plastic, caps, diluent) is sampled and tested against supplier Certificate of Analysis before acceptance.
- In-process checks: Random samples pulled during each production run for visual inspection, dimensional check, and closure integrity testing.
- Final release testing: Each finished batch tested for sterility (when applicable), particulates, and physical integrity. Batch released only after QC approval.
- Batch records: Each production lot has a complete batch record including raw material lot numbers, equipment used, in-process check results, and operator signatures. Records retained for 5 years.
- Customer-facing traceability: Every shipped product carries a lot number printed on the package. Certificate of conformity and batch records available within 1 business day on request.
Lot records on request
If your research requires documented material traceability (academic publications, regulated CRO work, etc.), email support@labvialpro.com with your order number and lot codes. We will email you a PDF Certificate of Conformity including raw material certificates, sterilization documentation, and QC release results within 1 business day at no charge.
What our products are NOT certified for
Our products are supplied for laboratory research and educational use only. They are not certified for:
- Human therapeutic, diagnostic, or consumption use
- Veterinary therapeutic or consumption use
- Direct food-contact applications
- Implantable medical device manufacturing
If your application requires medical device or pharmaceutical-finished-goods certification (ISO 13485, USFDA 510(k), CE Mark MDR, etc.), please source from a regulated medical device manufacturer.
Reporting a quality issue
If you suspect a quality issue with a product you received, email support@labvialpro.com within the 30-day return window with:
- Order number
- Product name and lot number (printed on the package)
- Description of the issue (and photos if applicable)
- Storage conditions since receipt
We respond within 1 business day. If the issue is confirmed as a quality defect, we replace the affected product at no cost or issue a full refund — your choice.
Continuous improvement
Customer feedback drives our QC priorities. If you have ideas for improvements to our process, products, or packaging — whether you're a chemistry professor, a CRO QC officer, or an independent researcher — we want to hear them. Email support@labvialpro.com.