Manufacturing

Where consistency is engineered, not hoped for.

A modern, fully-sealed facility with its own analytical, microbiology and stability laboratories — designed so that every batch leaves the same way it should: to specification, fully traceable, contamination-free.

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A fully-sealed plant, by design

Traceability that's real, not nominal

Excipient quality is decided long before the lab test. Our facility is fully sealed and contamination-controlled, so material moves from raw feedstock to finished powder without exposure to the environment. Every finished lot can be traced back to the raw material it came from, and the process it passed through.

Reactor tanks and pipework inside the Waylink processing plant
Reactor and process tank line

Engineered to order

Not a single standard grade — five variables, tuned to your process

Specific surface area

Tuned for lubrication efficiency — Magnesium Stearate to 20 m²/g.

Particle size distribution

Micronised through to nanoscale, matched to your blend and press.

Bulk density

Customised for Calcium Stearate to suit your blender, press or extruder.

Whiteness & mesh

Talc graded from 93–99% whiteness and 325–1200 mesh.

Physical form

Stearic Acid as flake, granule or powder to feed cleanly into your process.

The difference

Between an Excipient that "meets the monograph" and one that behaves exactly the way your process needs, batch after batch.

Warehouse with racked pallets of finished Excipient bags
Palletised, racked finished-goods storage

In-house laboratory capability

Nothing that affects your filing is outsourced

  • Analytical lab — assay, impurity and release testing.
  • Microbiology lab — microbial limit testing.
  • AAS instrument — heavy-metal and lead quantification on our own Atomic Absorption Spectrometer.
  • Stability chamber — shelf-life validation supporting the 60-month claim.
  • ETO treatment — microbial reduction where required.

Because heavy metals, lead and microbial limits are verified in-house, we can release against specification with confidence — and hand you a batch-specific CoA that means what it says.

See our full quality system →

Capacity in reserve

Headroom to absorb your growth and seasonal peaks.

5,000TCombined stearates / month
10,000TTalc / month
1,000TZinc Oxide / month
1,000kgPilot-lot starting point

You can qualify us on a pilot lot from 1,000 kg, then scale into container volumes on the same audited process.

Released only against specification

"Released against spec" is not a slogan. It's the gate.

Every batch is manufactured under WHO-GMP and ISO 9001:2015 (certified by IAF). Material that doesn't meet spec doesn't ship. That single discipline is why our customers see batch-to-batch consistency instead of surprises on the press.

FAQs

Manufacturing — common questions

Do you make Excipients to custom specifications?
Yes — surface area, particle size, bulk density, mesh, whiteness and physical form are engineered to order.
Is testing done in-house or outsourced?
In-house — analytical, microbiology, stability and AAS heavy-metal testing are all done on our own instruments.
What is your production capacity?
Around 5,000 T/month combined stearates, 10,000 T/month talc and 1,000 T/month Zinc Oxide, with headroom for growth.

Proof before promises

See the process behind the powder.

Request samples, a batch CoA, or a full plant and capability overview for your QA team.