A beta bag CoA and CoC come with every batch of DELTAQUANT 190 mm single-use beta bags, Empty or Pre-loaded, indA or indB, 10 L or 25 L. That is the standard documentation; it is listed as such on the documentation desk and it is not optional. This article explains what each certificate is for, what sits behind it, and what to ask for when your validation needs more.
Two certificates, one batch
The certificate of analysis, the CoA, reports the batch against its acceptance criteria: the tests that are run on a sample of every batch, with the method, the criterion and the result for that batch. The certificate of conformance, the CoC, states that the batch was made and released to the specification you ordered against: the configuration, the materials and the controls that apply to every batch. Read together, the CoA says what this batch measured and the CoC says what this batch is.
Both carry the lot. The carton carries the same lot, together with the configuration, the dates and a QR-coded GTIN, so a batch on the shelf can be matched to its paperwork without opening a carton.
What the CoA reports
Per-batch testing covers bioburden, endotoxin, particulates and weld strength. The limits and methods are published, and they are the same for every variety and volume:
- Bioburden: 1000 CFU/bag or less, by ISO 11737-1.
- Endotoxin: below 0.25 EU/mL, by USP <85>.
- Particulates of 10 µm and above: 20/mL or less, by USP <788>.
- Particulates of 25 µm and above: 3/mL or less, by USP <788>.
- Weld peel strength: 5.0 lbf/in or more, by ASTM F88.
The bag is also non-fiber-releasing under 21 CFR 210.3(b)(6). For indB the batch is released by dosimetry: the validated dose is 25–40 kGy for a sterility assurance level of 10⁻⁶, and dosimetric release is per batch.
The CoA reports the batch against these criteria. It does not report the type tests, the ones that qualify the design rather than the batch: alpha-port docking, multi-cycle docking, cover removal force, burst, seal dye penetration, film tensile and elongation, microbial barrier, transit and drop, steam compatibility, gamma compatibility and the sterility audit. For those the verification bench publishes the standard and the acceptance criterion, and the measured value appears when a batch report carries it.
What is checked on every bag
Three checks are applied to every bag, not to a sample, before the batch is released:
- A 100 % flange leak test by pressure decay, at 5 in. H₂O over 60 s.
- A 100 % visual inspection.
- Dimensional inspection to AQL 0.65.
These are release controls. They do not produce a certificate of their own; they are the reason the CoC can state that the batch conforms. The flange that goes out is a flange that held pressure, was looked at, and measured within Ø 190 ± 0.4 mm.
What the CoC stands behind
The specification the CoC refers to is the one on the products page: a flat pouch with the flange sandwiched into its face, compatible with industry-standard 190 mm alpha ports, in the ordered line, variety, volume and port version, built from eight parts in an ISO Class 7 cleanroom. The product-contact materials are high-temperature polycarbonate for the flange and the cover, platinum-cured LIM silicone for the beta seal, platinum-cured silicone for the O-ring, HDPE for the weld ring, a Tyvek® flash-spun HDPE microbial barrier for the outer porous film and multilayer LLDPE for the inner impervious film. The compliance references behind them are listed with the specification: USP <87> and <88> Class VI for biological reactivity, ISO 10993-1 for biological evaluation, FDA 21 CFR 177.1580, 177.2600 and 177.1520 for the food-contact polymers, BSE/TSE under EMA/410/01, REACH and RoHS, Ph. Eur. 3.1.5 for polyethylene with additives, and risk management to ICH Q9 and ISO 14971 by FMEA.
For Pre-loaded beta bags the CoC covers the bag. Units per bag, the sterilisation route of the kit and the validation are agreed per kit with you, and the paperwork for the kit follows that agreement rather than a published figure.
Matching the carton to the paperwork
- Each bag is overwrapped and tamper-evident sealed; the carton is the unit that carries the lot, the configuration, the dates and the QR-coded GTIN.
- Check the lot on the carton against the lot on the CoA and the CoC at goods-in, before the cartons go into storage at 13–27 °C and 30–60 % RH, away from sunlight, ozone and heat.
- The configuration on the carton is the one you ordered: line, variety, volume and port, and the kit for a Pre-loaded bag. The configurator writes the same configuration code on your request, so the order, the carton and the certificates read alike.
- Customer labelling and custom wrapping, triple wrap for example, are available on request.
Documents added on request
Five documents are prepared on request and sent with your quotation:
- Autoclave compatibility statement, for indA.
- Post-autoclave inspection protocol.
- Load-pattern guidance.
- Extractables summary.
- Validation package, under MNDA.
The first three belong with indA, where you run the autoclave cycle and need the statement, the inspection and the load pattern on file. The extractables summary and the validation package apply to either variety.
What the certificates do not do
They do not replace your validation. For indA the autoclave cycle is validated by you, in your autoclave; the statement and the protocol support that work, they do not do it. For Pre-loaded kits the validation is agreed per kit. And they do not carry measured values for the type tests ahead of a batch report; the bench says "awaiting batch report" until one does, and so does this page.
In practice
A component maker shipping stoppers, seals or ports to pharma customers in Pre-loaded beta bags passes the bag's CoA and CoC on with the delivery, so the receiving site has the lot, the per-batch results and the conformance statement before the bag reaches the port: see beta bags for component makers, recommended as Pre-loaded · indB · 25 L. On a fill-finish line the same two certificates are what QA files against the lot at goods-in: see beta bags for aseptic fill-finish. To see the certificates for a batch, request documents; sales replies within one business day.