• Hygiene inspection after VDI 6022
  • Space disinfection
  • Space validation and Raumklasifizierung
  • Plans for computer validation

Ventilation systems after VDI 6022

Analysis and Evaluation of the current GMP Status

Conduct of GMP inspections

Preparation for official inspections

Update of GMP- and QA-Systems

Review of QA systems and procedures

SOPs review and update

Training of personnel

Review and update of hygiene zoning concepts

Process validation support

Cleaning validation support

Validation of computerised systems

Qualification support

Supplier qualification

QC procedures: review and update

Water systems

HVAC systems

Quality manuals: preparation, review, and update

Review and compilation of Drug Master Files and Site

Master Files

Redevelopment of RLT plants

Redevelopment of ventilation systems and ventilation systems

Cleaning of ventilation systems and ventilation systems

  • Hygiene inspections of RLT plants according to VDI 6022
  • (RLT hygiene) RTL hygiene after VDI 6022 is accomplished every 2 years. Air duct cleaning and Luffkanaldesinfektion implement specialized company EIHRV. Air germ number must contain also poor copy test of the air ducts. Hygiene service consists of air duct cleaning with germ measurement evaluated in GMP Dokomentation in the form of test reports. Integrity test after VDI 2083 is part the pure space validation of RTL plants micro-biological spatial air investigations documents company in form GMP Prüfberichten.Partikelmessung must by technical personnel be measured.

  • Hygiene maintenance of RLT plant according to VDI 6022
  • Hygiene maintenance contains space disinfection with RTL Luftkanalreinigung. Pure space service defines VDI 6022 with VDI 2083. Clean-room technology qualifies the technical personnel with good GMP knowledge. Air duct cleaning takes place in accordance with VDI 6022. Air duct disinfection with particle measurement is a part the hygiene service of the RTL hygiene. Cleaning of processing air-technical plants is specially an area. Cleaning of RTL plant can take place if necessary on weekend.

  • Air duct cleaning
  • Air duct cleaning after VDI 6022 takes place in accordance with cleaning plan. Cleaning of the RTL plant is gefordet in VDI 6022. Pure area air duct cleaning will become every 2 years accomplished and if necessary maintenance master plans the maintenance plans to contain. Cleaning of the ventilation system takes place in accordance with operating diagrams. Air duct disinfection is part of VDI 6022.

  • Space disinfection
  • Pure space hygiene service

    Air duct disinfection after VDI 6022 is a part hygiene services space disinfection documents specialized company in test reports with photo documentation. The technical personnel leads GMP Konsulthing for pure space validation over for the GMP audit good preparation to meet. As possess 15 years experience around GMP documentation such as validation master plans to provide. Space disinfection is part of the pure RAM validation. In accordance with maintenance master plans and cleaning plans knows our company the air duct cleaning with space disinfection would drive out. Reduction of the RTL plant effected after GMP documentation and must document GMP Consulting in test reports.

  • Particle measurement
  • Particle measurement with particle number regulation after VDI 2083 is part the hygiene service. Pure area service is accomplished after VDI 2083 and is part of the pure space validation. Except particle measurement in air duct poor copy test must plus germ measurement accomplished. Filter licked after VDI 2083 is important for pure space validation. Pure classes of area particle measurement after VDI 2083. Seal the HEPA filter must for RTL plant within the range Pharma pure area be measured.

  • Germ measurement
  • For germ number regulation we use Luftkeimsampler with calibration certificate. Pure class of area regulation must according to DIN EN ISO 14644 accomplished. FF in air duct of the RTL plant can determine micro organisms. Before the air duct disinfection air duct cleaning must take place. Before the pure space validation we provide a risk analysis after FMEA.

  • Space validation
  • Before the pure space validation we provide a work statement after GMP navigator. Then product requirement specifications are provided. Validation as well as qualification of RTL plants are to take place in GMP documentation in the form of test reports. GMP documentation consists function qualification and achievement qualification of Design qualification and installation qualification in connection is provided. We work on pure space validation as well as clean-room technology after V-Model.

  • Hospital hygiene
  • Hospital hygiene (VDI 6022) must take place according to DIN 2167. Hospital service contains pure space disinfection as well as air duct cleaning. Hygiene maintenance consists of Keimmzahlbestimmung and flow visualization. If necessary filter exchange is accomplished and provided GMP documentation in the form of inspection reports. Part the clean-room technology as well as hygiene maintenance is integrity test after VDI 2083.

  • Filter change
  • If necessary we can offer also filter changes and provide maintenance plans after VDI to 6022. We can supply the HEPA filters. We register protective measures in the maintenance master plan. Hygiene inspection in the pure area takes place after SOP of the specialized company.

  • GMP Consulting
  • GMP Consulting as well as audit preparation are to be thoroughly prepared before the audit, in order to exist audit well. We are able GMP training would drive through. We support S. emphasis with production of load reports as well as SOP `are production of validation master plans. We would drive 4 V-Model for plant qualification out after GAMP.

  • Risk analysis according to FMEA
  • Risk analysis after FMEA is provided for plant qualification and process validation. We provide after FMEA for Computervaliderung 21 CFR part 11 to risk analysis. Computer validation is accomplished in accordance with FDA 21 CFR part 11. European Institut provides risk analysis after FMEA for hygiene inspection after VDI 6022.

  • Plant qualification
  • We provide DQ and IQ for plant qualification. Our specialized company possesses examples of OQ and PQ for plant qualification. Hygiene inspection can be qualified if necessary after V-Model. We possess over 15 years experience in clean-room technology.

  • Computer validation
  • We have mehere years experience for computer validation after CFR 21 part 11. Computer validation can be accomplished after GAMP 4. We can provide validation plans as well as validation reports for you. We provide GMP conformal documentation.

  • GMP documentation
  • The validation master plans and qualification plans are provided. We have examples of Wartungsmasterplänne and operating diagrams. Our emphasis are GMP conformal hygiene inspection reports. We have cleaning plans for several customers to prepare. We support you with production of load reports with the validation.

  • Pure class of area regulation
  • Pure class of area regulation according to DIN European Union ISO 14644 can be documented if necessary. We determine particle number in air. The inspection devices we particle counters are calibrated active casual and have certificates. We have 15 years experience in GMP documentation for hygiene examination after VDI 2083. Germ number regulation and provides GMP documentation. Hygiene examination of the RTL plants after VDI 6022 must take place all 2 to 3.

  • Integrity test according to VDI 2083
  • We would drive integrity test out of the RTL plants after VDI 2083. Tightness of the filters must be examined during hygiene maintenance. After the examination we lead pure space disinfection. Our work area are RTL plants as well as laminar flow cabs. Clean-room technology is a term for maintenance and pure space measurement.

  • Test EIHRV
  • We provide SAT Testpläne. Our company can prepare FAT Testpläne air duct cleaning of the RTL plant in GMP form is documented. Cleaning of the RTL plants and hygiene examination is if necessary on weekend passage-leads.

We are a service enterprise, specializing particularly in hygiene inspections according to VDI 6022, air duct cleaning, space disinfection, clean-room technology, validation, plant qualification and GMP consulting. Our authority is based on 17 years experience in the Pharma industry. In our enterprise you will find fast technical problem solution, service, consultation and support by experienced engineers and technicians.

In any areas of the designated you find fast access to our competent assistance 24 hours per day.