Environmental monitoring

We provide support within

  • Planning
  • Trend reporting & reporting

We do the qualification of cleanrooms

  • Design (URS)
  • Risk assessments
  • Preparation of SOPs
  • Protocols/reports (IQ, OQ, PQ)
  • Training

Qualification & validation of controlled environments and clean rooms

Support for URS, FS, DS IQ:

Here we can provide both service when it comes to protocol, test plans and, not least, reporting.

OQ

If you want assistance with protocol, test plans, reporting & SOPs, we can help.

PQ

We offer services in relation to risk assessment, selection of test sites, germs and particles in air, germs on surfaces, protocol, test plans, report and validation deviations.

Routine monitoring,

With routine monitoring, we are experts in setting up programs, reporting/trend reports and training.

With more than 20 years of experience in qualifying & validating cleanrooms, we are experts in:

  • Guidance for Industry, Sterile Drug Products Produced by Aseptic processing cGMP, FDA September 2004
  • GMP ISO 9001:2015 (quality)
  • ISO 14644-1: Cleanrooms and associated controlled environments – part 1: Classi cation of air cleanliness, rst edition, 1999-05-01
  • FDA Guideline on Aseptic Processing, 2003
  • EU cGMP Guideline, Annex 1, manufacture of Sterile Medicinal Products, February 2008

Do not hesitate to contact us to hear more

+45 59 45 13 68

AL Engineering A/S
Tuse Næs Vej 7C
DK-4300 Holbæk
Phone +45 59 45 13 68
Email: info@al-engineering.dk
VAT: 25730011

Privatlivspolitik

+45 59 45 13 68
info@al-engineering.dk
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