JLR PROJECT SA

WHO ARE WE?

JLR PROJECT has been active on the territory since the beginning of 2014, within the pharmaceutical industries and healthcare professionals, and has become a leader in cleanroom controls, qualification of related equipment, calibration and process validation..

Always listening to our customers, our know-how meets your needs with precision and efficiency. To ensure this, we have qualified, regularly trained personnel and a large stock of calibrated equipment.

Our quality management system has been recognized and certified according to the requirements of ISO9001:2015..

Our proximity agencies based in Boudry (NE) and Gland (VD), our availability and our involvement enable us to respond efficiently and quickly to the requirements of the standards, authorities and regulatory inspections in force.

OUR ACTIVITIES:

– Qualification of clean rooms and related controlled environments according to ISO 14644-1 and 3 + Good Manufacturing Practices (GMP).

• Particle counting
• Recovery test
• Emery integrity test (leakage from an installed filter)
• Pressure drop control of THE filters
• Air volume flow / Air velocity / ACR / Uniformity of laminar flow
• Differential air pressure
• Measurement of temperatures and hygrometry
• Airflow visualization with video recording
• Containment leakage
• Checking the pressure gauges in place
• Noise
• Light

– Control of biocontamination according to ISO 14698-1 and 2 standards.

• Measurement of aerobiocontamination
• Measurement of surface bio-contamination
• Incubation and colony counting performed in-house
• Identification of colonies if the defined target level is exceeded, contracted out to an accredited laboratory

– Qualification of related equipment

• BSC (Biosafety Cabinet) according to ISO 12469
• Chemical fume hoods and chapels (fume cupboards) according to ISO 14175-3

– Qualification of compressed air networks according to the ISO 8573 standard

• Network pressure
• Dew Point
• Bacteriological
• Counting
• Hydrocarbon content

– Metrology of on site measuring instruments

• Calibration of temperature, humidity and pressure sensors
• Calibration and maintenance of micropipettes

– Characterization/Verification of thermostatic or climatic chambers according to IEC60068-3 and FD X 15-140 standards.

– Characterization/Verification of autoclaves

– Characterization/Verification of washer-disinfectors

– Checking and maintenance of centrifuges

– Checking and maintenance of scales

– Filter replacement and minor maintenance

– Training and coaching in clean room (hygiene, behaviour, norms…)

– Audit and technical expertise of secondary installations (HVAC, Containment, Hot, Cold…)

– Support on a contamination control plan