Qualifications – IQOQPQ – B. Doucet Lab Services Inc.

Validation Services for Life Science & Regulated Industries

BDLS offers a wide variety of validation services that meet Health Canada, FDA, and many European standards. Although our primary focus is on that of the pharmaceutical and biologics industries, we also execute required studies for food and beverage, cosmetic, industrial, and medical device companies.

Equipment Validation

Autoclave Validation

Temperature mapping of Load patterns
Use of Biological Indicators to prove biological kill
Measurement of Lethality to prove steam penetration
Calibration of pressure gauges and temperature probes are part of each validation

Cold Storage Temperature Mapping

24-hour loaded, empty, or as-is mapping available
Open door and power failure recovery studies
Calibrations with in line recorders, building monitoring systems, and
digital display
Use of NIST traceable wireless or standard data acquisition systems for
all studies
Protocols reviewed and approved by the customers before the technician arrives
on site for testing

Stability Chambers, Incubators, and Warm Storage

Capabilities for mapping temperature, humidity, as well as CO2
Stability chamber validations consistent with ICH guidelines or customer
quality systems
24-hour loaded and empty mapping or as-is mapping available
Open door and power failure recovery studies
Calibrations with in line recorders, Building monitoring systems,
and digital display
Use of NIST traceable wireless or standard data acquisition systems
for all studies
Protocols reviewed and approved by the customers before the technician
arrives on site for testing

Oven Validations

Temperature map vacuum ovens under vacuum and perform pressure leak tests
24-hour temperature mapping on laminar flow, convection ovens, and furnaces (up to 1200C) Note: mapping times will vary depending on the temperature range
Calibrations with in line recorders, Building monitoring systems, and digital display
Use of NIST traceable wireless or standard data acquisition systems for all studies
Protocols reviewed and approved by the customers before the technician arrives
on site for testing

Warehouse and Storage Facility Mapping

Capabilities for mapping temperature and humidity
Seasonal studies (winter, summer)
Scaling as required (hundreds of traceable probes are available)
Calibrations with in line recorders, Building monitoring systems,
and digital display
Use of NIST traceable wireless or standard data acquisition systems
for all studies
Protocols reviewed and approved by the customers before the technician
arrives on site for testing

Laboratory Equipment Validation

Balances – IOQs meeting USP 41 standards
Centrifuges – IOQs testing for control, RPM, time, and temperature
Spectrophotometers – IOQs for wavelength accuracy, wavelength linearity, photometric linearity, etc. using Holmium oxide, Potassium chloride and other filters
Melting Point Apparatus – IOQs for multiple melting point accuracies over full scale range
Use of NIST traceable standards for all testing and in many cases, use of 17025 accredited standards
Protocols reviewed and approved by the customers before the technician arrives on site for testing

Calibration & Verification

Can your equipment still meet its design specifications? Verification and calibration can let you know if your equipment is providing accurate results.

BDLS uses NIST traceable equipment with high quality standards that far exceed the accuracy of general lab equipment, ensuring a proper verification and/or calibration of the result from your equipment.

Repair

Is your equipment broken or producing unreliable results? We have some of the repair industries widest range of serviceable equipment. Over and above this, our turnaround time is unparalleled by our competitors. We take pride in always exceeding our clients expectations when it comes to the value received from our repair services.

Preventive Maintenance

How will it affect you if the equipment you rely on is suddenly not working? Performing regularly scheduled preventive maintenance will help to avoid unplanned equipment downtime. Maintenance is the easiest way to save costs and maintain productivity in the lab.