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Certificates

Five steps, in order

Five steps, one building

Synthesis, purification, lyophilisation, fill and finish, release testing. Every one of them runs here, and every one of them is written down.

A process is what a record is kept of.

05Steps, each with its record

Jacketed synthesis reactor with a resin column on its frit, the solvent lines and the drain below.

Station 01SynthesisScroll indexes the track

The five steps

Five controlled steps between a sequence and a sealed vial.

  1. 01

    Synthesis

    Sequences are assembled by solid-phase peptide synthesis, residue by residue.

    What enters
    A protected amino acid sequence and the resin it is built on.
    What happens
    Residues are coupled one at a time on the resin, then the finished chain is cleaved from it.
    What is checked
    Each coupling is checked before the next residue is added.
    What leaves
    Crude peptide in solution, with its sequence recorded.

    Why it mattersThe sequence is assembled in this building. It is not bought in and relabelled.

  2. 02

    Purification

    Crude peptide is purified by preparative HPLC. Fractions are pooled against the purity specification.

    What enters
    Crude peptide from synthesis.
    What happens
    The crude is separated by preparative HPLC and the target fractions are pooled.
    What is checked
    Fractions are pooled against the purity specification, not by eye.
    What leaves
    Purified peptide in solution, ready for drying.

    Why it mattersPurity is made at this step. Release testing confirms it later; it does not create it.

  3. 03

    Lyophilisation

    The purified solution is freeze-dried into a stable cake.

    What enters
    The purified solution, dispensed into its trays.
    What happens
    It is frozen and dried under vacuum into a stable cake.
    What is checked
    The cake is inspected through the glass before it moves on.
    What leaves
    A dry cake, stable at the condition printed on the label.

    Why it mattersA lyophilised cake is what lets a peptide be shipped and stored as a solid.

  4. 04

    Fill and finish

    Vials are filled by mass, stoppered and crimp-sealed with an aluminium cap.

    What enters
    Lyophilised material, tubular glass vials, stoppers and aluminium caps.
    What happens
    Each vial is filled by mass, stoppered and crimp-sealed in a controlled area.
    What is checked
    The fill mass, and the seal after crimping.
    What leaves
    A sealed vial with its lot number printed on the label.

    Why it mattersThis is the one step the vial is open, and it happens in a classified environment.

  5. 05

    Release testing

    Each lot is tested for HPLC purity and pH, then released with its certificate.

    What enters
    Sealed vials from the lot.
    What happens
    The lot is tested for purity by HPLC and for pH, and the results are compared with the specification.
    What is checked
    Both results, against the written specification. A lot that does not meet it is not released.
    What leaves
    A released lot with its certificate of analysis, or a held lot.

    Why it mattersRelease is decided once per lot, against a specification and never against the previous lot.

Schematic. No lot values are shown. No temperature, pressure, cycle time, column dimension, batch size or yield appears on this page.

Provisional

The five process steps and their station detail, as worded

Each step has a control and a record

Nothing moves to the next step on judgement alone. Each transfer is checked and written down.

1A/012A/023A/034A/045A/05In-process control pointsBatch record
Plan view. A control point sits at every transfer, and a record card is docked under every control point.
A / 01Coupling is checked at each residue before the next is added.
A / 02Fractions are pooled against the purity specification, not by eye.
A / 03The cake is inspected through the glass before the stopper is seated.
A / 04Fill is by mass, and the seal is checked after crimping.
A / 05Purity and pH are tested before the lot is released.

The batch record carries every check for the lot it belongs to.

Provisional

The five in-process control lines, as worded

  • 05Control points
  • 01Batch record per lot
  • 02Release tests
Analytical bench with a balance under its draught shield and a pH meter with the probe in its holder.
Control A / 05 sits on this bench. Both displays are blank, because a reading belongs on a certificate and not on a website.
Interlocked pass-through hatch set in a coved wall panel, with a sealed tub staged behind its inner door.

The vial is open for one step, in a classified environment

Filling, stoppering and sealing happen in a controlled area. Components enter through a pass-through, not through the door.

Pass-through hatchBoth doors never open at onceScroll runs the interlock

A moulded nest of grey butyl stoppers seated in their pockets inside an open tub.
Closures are staged in a moulded nest inside a sealed tub, and the tub enters through the hatch.
Components are staged in sealed nests.
Operators are gowned and work to written procedure.
The environment is classified to ISO 14644-1.

Classification of the filling environment

ISO 14644-1 class

The class of the filling environment is stated once it is confirmed. An empty field is worth more than an invented one, so the slot is left empty.

Provisional

The class of the filling environment, and the empty slot that stands for it

The plant behind the catalogue

The laboratory runs the equipment each step needs. Nothing in the five steps is subcontracted.

  • Lyophiliser chamber with four shelves, a loaded tray of vials and the condenser behind its separating valve.

    Step 03

    Lyophiliser

    Shelves and condenser. Freeze-dries the purified solution into a cake.

  • Preparative chromatography column with its end fittings, the detector cell downstream and the fraction collector arm over its rack.

    Step 02

    Preparative column and detector

    Separates the target from the crude mixture. Fractions are collected downstream of the detector.

  • Filling and stoppering line, with an indexing track of vials, the fill head above the track and the stoppering head beyond it.

    Step 04

    Filling and stoppering line

    Fills by mass and seats the stopper. The track indexes one station at a time.

  • Crimping head with the collet jaws closed on the aluminium skirt under the neck flange of a vial.

    Step 04

    Crimping head

    Closes the aluminium cap over the stopper. The jaws roll the skirt and never touch the glass.

  • Analytical bench with a balance under its draught shield and a pH meter with the probe in its holder.

    Step 05

    Analytical bench

    Balance and pH meter for release testing. Both displays are blank on purpose.

  • A rack of retained vials in rows, each carrying a lot field on its label.

    After release

    Retention rack

    Holds a retained sample from every lot, each with its own lot field.

Swipe through the stations

No brand, model, capacity or serial is named. The step index ties each machine back to the process spine.

Provisional

The equipment list as a list of what the laboratory owns, and the retention rack with any retained-sample policy

  • 06Stations
  • 05Process steps covered
  • 00Steps subcontracted

What the process produces

A sealed vial with a lot number, a batch record that carries every check taken on the way to it, and a certificate of analysis issued against the specification. Nothing is released before those three exist.

Look up a lotQuality system

Enquiries

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