Question 1

What is EU GMP hydrocarbon extraction equipment?

Accepted Answer

EU GMP hydrocarbon extraction equipment is closed-loop light-hydrocarbon extraction machinery specified so it can be qualified and operated inside a facility manufacturing to EU GMP. In practice that means cleanable stainless product-contact surfaces, a control system whose records can be trusted, and documentation an IQ/OQ/PQ can reference. Decimal's hydrocarbon platforms are the 15.HX and the 75.HX.

Question 2

What is EU GMP ethanol extraction equipment?

Accepted Answer

EU GMP ethanol extraction equipment is chilled-ethanol extraction machinery built to the same qualification and cleanability expectations, with the added benefit that ethanol is a Class 3 solvent under ICH Q3C and therefore carries a comparatively permissive residual-solvent limit. Decimal's ethanol platform is the 20.EX, a chilled centrifuge extractor.

Question 3

Should I choose hydrocarbon or ethanol extraction for a GMP facility?

Accepted Answer

Choose hydrocarbon when the product is a terpene-forward concentrate — live resin, badder, dabbable material — and you can support a C1D1 room. Choose ethanol when the goal is bulk crude or distillate feedstock, winterization is already part of your process, and you want a Class 3 solvent to simplify the residual-solvent argument. Neither method is favoured or prohibited by EU GMP; what changes is where the validation effort lands.

Question 4

What is the difference between the 15.HX and the 75.HX?

Accepted Answer

Scale and shift structure, not method. The 15.HX is the mid-scale hydrocarbon platform for an operation running defined production shifts with tight batch control. The 75.HX is Decimal's largest hydrocarbon system, roughly double the scale of the 40.HX, intended for continuous multi-shift hydrocarbon production. Both use the C1D1 explosion-proof touchscreen tablet interface that runs across the HX line. The 75.HX is configured per order, so its capacity, throughput and utility figures are confirmed directly by Decimal Engineering rather than published as a fixed specification sheet.

Question 5

Is the 20.EX suitable for an EU GMP facility?

Accepted Answer

The 20.EX is designed to support EU-GMP facility compliance, and its centrifuge, umbilical control panel and tablet are C1D1 rated. It is important to be precise about what that means: no extractor is itself "EU GMP certified". EU GMP certificates are issued to sites by a competent authority after inspection, not to machines. Equipment supports that outcome by being cleanable, qualifiable and documented.

Question 6

Are Decimal extraction systems EU GMP certified?

Accepted Answer

No, and neither is any other extractor. EU GMP certification applies to a manufacturing site, awarded to the site after a competent-authority inspection. Decimal designs for that outcome rather than claiming it: ASME code construction is available on qualifying pressure vessels, UL-recognized components are specified in the electrical package, and the documentation package is built to be referenced by your qualification protocols. Any supplier claiming a machine-level EU GMP certificate is describing something that does not exist.

EU GMP Hydrocarbon & Ethanol Systems