Case 1: Capsule Filling Machine

PEC has recently completed a project with a major pharmaceutical company, creating a production-ready capsule filling suite. PEC contributed with their experiences to ensure technical solutions were optimised through the project life cycle and were the primary resource for the qualification package.

Technical Description

An MG2 Planeta 100 is a continuous capsule filling machine, which includes 4 separate, but identical dosing systems The Planeta machine opens empty capsules. Preset volumes of micro-particles are injected into the capsule and then the capsule is closed. The bore of the dosing rings and the consistency of dosing pin tolerances are critical attributes for dosing accuracy. Sampling systems, to allow weight checks of dosed capsules, is integrated into the machine. There is product contact throughout the filling process.

Qualification Scope

The qualification package consisted of the creation and execution of the following documents through the project life cycle.

  • Functional requirement Specification(FRS; Including quality requirements, impact assessments and a definition, with rationales, to which devices, parameters, alarm, interventions and batch data have a direct impact on product quality.
  • Enhanced Design Review Report
  • FAT Protocols & Reports
  • Requirement Traceability Matrix
  • Commissioning Protocols & Reports
  • IQ/OQ Rationales, Protocols & Reports
  • Qualification Summary Report (QSR)
  • O&M Manual Reviews

Achievements

The capsule filling equipment, required for the customer's application, required a highly complex process and control systems. PEC gained sufficient process and technical understanding to ensure that the capsule filling machine's functions were optimised and to ensure that the knowledge gained within the project phase was adequately transferred across to customer staff. This included the following technical functions:

  • SWC Systemt
  • Nett System (capacitive measurements converted into a net capsule weight)
  • Single Pellet Dosing
  • Electronic Records and Signatures
  • Audit Trails
  • Connection to Database

and was achieved by:

  • Process understanding of the relevant technical areas being documented throughout the project
  • Resulting conclusions being included as part of the equipment FRS

PEC used the customer's Commissioning and Qualification System (CQS) for the initial creation of qualification documents. In order to perform this successfully, a Microsoft Groove database and customer extranet was provided, in order that documentation was able to be created and controlled from PEC's offices.

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