Certificate of Analysis

Certificate Lookup

Look Up Your Certificate of Analysis

Every lot is functionally tested for qPCR purity. Enter your product and lot number to view or download your lot-specific CoA.

Both fields are printed on your product label and packing slip.

Can't find your lot number? Contact us at info@pcrseal.com and we'll send your CoA directly.

We Test the Film. Not Just the Process.

Most sealing film brands certify their manufacturing process and call it a day. We certify the product you actually receive — every lot, every time.

Lot-Level Functional Testing

Every production lot is manufactured in a Class 100K cleanroom, visually inspected, and then put through a full panel of functional testing before it ships. Not a sample from a batch. Not a periodic audit. Every lot.

qPCR Performance
Amplification efficiency validated using 10-fold serial dilution, with R² determination
PCR Inhibitor Assay
Tested to confirm zero inhibitory compounds that could suppress amplification
Biological Purity
Human DNA-free (L1 sequence PCR), DNase/RNase-free, ATP-free (luciferase assay)
Endotoxin Control
Non-pyrogenic per LAL method, in accordance with USP33 <85>, <161>, and FDA guidelines
Evaporation QC
Seal integrity verified through thermal cycling to ensure no sample loss
Functional Adhesion
Reliable seal performance, clean peel, and consistent optical clarity validated per lot

Manufacturing Standards

PCRSeal products are manufactured in compliance with internationally recognized quality management systems:

ISO 9001:2015
Quality management systems — controlled production processes, documented traceability, and continuous improvement
ISO 13485:2016
Medical device quality management — designed for life science and diagnostic consumable manufacturing

These certifications govern the manufacturing process. Our lot-level functional testing goes further — it validates the product itself.

Regulatory & Material Compliance

All raw materials and finished products meet applicable environmental, safety, and food-contact material standards:

RoHS 2011/65/EU — compliant with restriction of hazardous substances
REACH (EC) No 1907/2006 — Non-SVHC, compliant with EU chemical safety regulation
U.S. FDA 21 CFR 177.1520 (3.2a) — materials meet food-contact polymer specifications