The Importance of Quality
The Quality Assurance and Control program is an essential function of MB Laboratories Ltd. The purpose of the program is to ensure the reliability and validity of all analytical results. Our Quality Assurance (QA) program specifies policies and procedures that assure the integrity of analytical data and demonstrates our commitment to quality. Our policies are consistent with regulatory guidelines and meet or exceed industry standards.
Information Management
LIMS5, the Laboratory Information Management System developed by MB Laboratories Ltd, handles all of the sample log-in, scheduling, QC data, test results, routine calculations, reporting and sample storage assignments for the laboratory.
The laboratory utilizes a number of specialized, proprietary programs for many of its professional services. These include SWAMI, a professional taxonomy program for microbial identification, and Buglister, a comprehensive database and reporting tool for fungi, bacteria, yeast and algae/protozoa.
Standard Operating Procedures (SOP's) are used to define and describe each routine analysis performed by our laboratory. SOP's include information on the following topics:
- Sample collection, preservation and holding time
- Sample receipt, custody and document control
- Analytical method
- Instrument calibration and maintenance
- Quality control
- Safety and Hygiene
- Confidentiality
Analytical methods are derived from standardized protocols and guidelines provided by the EPA, APHA, NIOSH and ASTM. Any analytical method that deviates from these guidelines is thoroughly documented by laboratory staff.
Routine quality control measures include:
- replicates, spikes, blanks, standards, & primary certified reference material
- unusual results or values that are at or over regulatory limits are routinely verified by an alternate analytical method.
Facilities & Personnel
Physical
4,000 square feet, well ventilated and air-condition to provide a stable ambient temperature 20-22C
- walls are finished and have washable surfaces – floor is finished with vinyl commercial grade tile.
- uniform glare – free lighting is provided from full – spectrum bulbs and specialized areas are provided with additional halogen lamps
- each analyst has in excess of 2 meters of bench space – all work benches are laminate
- all sink areas are continuous stainless steel
- separate physical areas are provided for wash-up, preparation and sterilization, sample receiving, holding, and analysis.
Maintenance
- the laboratory floors are professionally cleaned on a contract basis
- all benches and sink areas are washed and disinfected daily
Air Quality
- Air filters on the air-conditioning unit are inspected and changed monthly
- airborne microbial contamination tested monthly or as required
- extensive airborne chemical contaminants are tested quarterly
- laminar airflow hoods are tested daily for airborne contamination
Laboratory Classification
The laboratory is maintained and classed as a level 2 containment, level 3 handling facility. All criteria set out by Health Canada, CFIA and WCB are maintained and enforced.
Personnel
- all permanent laboratory staff are graduates of technical training in laboratory procedures (diplomas) and/or have post-secondary degrees (University BSc).
- many of the professional staff hold advanced degrees or training (Masters, Doctoral or Technical Specification Ratings in Registered Technologies)
- in-house training programs take 1-4 years.
- temp (eg. summer students) positions are closely supervised and are not allowed to proceed with any task alone.
- handling of materials and samples containing high titres of microbes is restricted to trained personnel who have proven aseptic techniques (including chemists). All personnel must undergo training as outlined in our manuals.
Reference Standards
Microbiology
The company maintains an extensive culture collection. The collection includes certified reference strains from recognized sources such as American Type Culture Collection, US Food and Drug Administration and US Environmental Protection Agency; industrial strains and research isolates. These micro-organisms are used both for routine QC functions and for on-going research projects.
Chemistry
Certified reference material and standards are purchased from a variety of reliable suppliers.
Analytical Methods
The laboratory follows established, published, validated methodology whenever possible. Analytical methods that are professional or specialized tests are conducted by a qualified professional or have been fully validated as per International Harmonized and US Pharmacopeia.
Primary Method References
- Pharmacopeia - USP 44 NF33 (2015)
- Pharmacopeia - Sch B F&DA including EU, IP (Internationally Harmonized methods WHO) and Canada's Compendia
- BC Environmental Laboratory Manual (BCELM)
- Standard Methods for Examination of Water & Wastewater (SM)
- Association of Analytical Communities (AOAC) Official Methods
- US Food & Drug Administration Bacterial Analytical Manual (US FDA/BAM)
- US Environmental Protection Agency Analytical Methods (EPA)
- International Subcommittees on Taxonomy, IJSB & Bergy's Systematic Bacteriology
RELEVANT INFORMATION
Microbial Analysis Methods & References (Micro Methods & References.doc)