Renka - Vorschau

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RENKA
Growth vertical / Pharma GMP

Pharma / GMP.

Mechanical cleanroom installation in sterile pharmaceutical plants and biotech. EU GMP Annex 1 (effective August 2023) has triggered a retrofit wave across 150-200 sterile EU sites. Renka delivers the HVAC and cleanroom mechanics for those projects.

Anonymised pharmaceutical cleanroom photograph: operator at a RABS isolator under unidirectional airflow, Grade A environment.
Pharma GMP Grade A, RABS isolator, anonymised
Annex 1 - mechanical implications

What has changed for HVAC mechanics.

  • Unidirectional airflow 0.36 - 0.54 m/s in Grade A zones, fully documented
  • HEPA H14 mandatory for Grade A (previously H13 tolerated)
  • Pressure cascade validation with continuous logging
  • RABS and isolators mandatory for new aseptic lines
  • Contamination Control Strategy (CCS) as an integrated document
  • Pre-use post-sterilisation integrity tests for sterilising-grade filters

Source: EU GMP Annex 1 (Aug 2022, in force Aug 2023)

Scope

What Renka delivers.

  • Complete mechanical cleanroom installation Grade A - D
  • RABS and isolator connection to supply lines
  • HVAC engineering and installation for sterile manufacturing
  • UPW and process media pipework (orbital welding)
  • IQ/OQ support and documentation
Prequalification

Request pharma GMP capability sheet.

Annex 1 experience, RABS/isolator projects, IQ/OQ documentation capability.

Request dossier →