What Is Pathology and Pathogen Facility and Containment Testing?
Biocontainment facilities for pathology and pathogens allow for the research and clinical diagnosis of emerging infectious diseases. A pathogen and pathology containment system is an enclosed ventilated laboratory workspace, and the different types that exist are distinguished by the level of biocontainment.
The concept of biocontainment relates to laboratory biosafety and concerns microbiology laboratories where the physical containment of pathogenic agents or organisms (toxins, viruses and bacteria) is required, usually by isolation in environmentally and biologically secure rooms or cabinets, in order to prevent accidental infection of workers or release into the surrounding community.
Since pathogen and pathology containment is used as a primary containment barrier when operating in environments such as hospitals and research centres with hazardous compounds or infectious agents, such units must be reliable.
Biological containment is a public health issue and failure can have far-reaching, and often very serious impacts.
At least once a year, the equipment must be inspected and validated by trained personnel; usually technical or mechanical engineers specialised in the maintenance and testing of this type of equipment.
This validation process is called Pathology and Pathogen Facility and Containment Testing.
Total Clean Air is a well-known company in the UK when it comes to Pathology and Pathogen Facility and Containment Testing.
We have the qualified personnel and state-of-the-art equipment to carry out Pathology and Pathogen Facility and Containment Testing. Call 01737924700 to find out more about this service or book a test today.
Total Clean Benefits
- All Work Is Guaranteed
- Full Manufacturer Warranty
- ISO Accredited Validation
- Operational Qualification
- Performance Qualification
- References Available
Types of Pathogen Containment
Primary Containment
This is the main container in immediate connection with the biohazardous material. It also protects the immediate laboratory environment from exposure to infectious agents and offers personnel protection.
Primary containment requires the use of appropriate containers for storage, excellent microbiological procedures and the utilisation of suitable safety equipment, such as a biological safety cabinet. BSCs (biological safety cabinets) are devices designed for laboratories working with highly infectious agents and can provide effective primary biocontainment.
There are three general levels and types of biological safety cabinet — Class I, Class II, and Class III.
- Class I: Only serves to protect the operator. These are open at the front and the air is drawn in completely through the front opening.
- Class II: Protects both the operator and the work area. These are also open-fronted and the air is drawn in through the front. However, it draws air in through a HEPA filter before it blows over the work area. This pathogen containment must be used with caution. A risk assessment will determine which BSC class to use.
- Class III: Provides full protection both for the work and the user. These are completely sealed with glove ports and a HEPA filter draws air into the cabinet. Accordingly, a solid barrier separates the operator from the work.
Secondary Containment
This is equipment that protects outside the laboratory from exposure to infectious components and is provided through a blend of operational practices and facility design.
The laboratory and its facilities are tested often to ensure that the requirements indicated by the HSE, department and research groups, as well as relevant international safety standards are met before work begins.
This demands the expertise of a competent person such as those employed by Total Clean Air.
Total Clean Air have the qualified personnel and state-of-the-art equipment to carry out Containment Testing in critical facilities and cleanroom environment.
Management and Operation of Microbiological Containment Laboratories
From a biosafety perspective, best practices for the safe work environment in clinical and biomedical laboratories emphasise that regular tests be performed, classifying the risks into two major types: hazard of the laboratory procedure and hazard of the agent.
The containment facilities are complex and require a great deal of knowledge and experience for their construction and operation.
Maintenance staff and a biological safety professional should assist in maintaining the facility to provide effective protection for planned work and suggest changes where necessary.
Experts consultants can also be engaged to provide expertise on containment laboratory management.
Total Clean Air can provide experts who can perform this role optimally.
Design
Pathogens and pathology containment laboratories are designed and constructed to control or prevent exposure to the biological agent in use by people, laboratory workers, and the environment.
Biological agents are classified into 4 Hazard categories based on how infectious they are and the effects of such infection.
The containment levels usually required for working with these agents are defined by their categorisation. The safety equipment which is the primary barrier contains the source threat, and the laboratory itself which is the secondary barrier is designed to protect those outside the laboratory and the workers.
It is also important to recognise that the secondary barrier often represents a protective barrier that prevents entry, unless strictly monitored, of all but those who are highly equipped and knowledgeable.
At Total Clean Air, we can design pathogen and pathology containment that meets the following criteria:
Flexibility and adaptability
Modular design that makes the laboratory future-proof with minimal change to the physical layout for various work programs.
Construction services
Exhaust ventilation both local and general will be provided. It is appropriate to provide humidity and temperature controls which will provide comfort to the operator and meet any special facility or equipment requirements. Service and Controls areas are located, where possible, away from the actual laboratory areas.
Space and function
The various aspects of the research can be considered and placed appropriately in a new laboratory facility, for example centralised support facilities within a complex for individual laboratories
Population of workers
Fully understanding the number of personnel likely to work in a pathogen containment area will give a picture of the size restrictions and the size of the room.
Ergonomy
The laboratory design will also adopt relevant ergonomics principles, i.e. by tailoring the work to the employee.
Apart from providing sufficient artificial and natural lighting, healthy work humidity/temperature will also contribute to environmental comfort and a positive impact on safety and health.
The laboratory will also be large enough to allow sufficient ‘free air’ space for each worker. Each room will be designed to have enough unoccupied space, height, and floor area for welfare, safety, and health purposes.
Testing
It is recommended that the laboratory and its equipment be tested to ensure that the standards set by the HSE department, research groups, and international safety standards are met before work begins.
Several key factors will also be tested, in addition to carefully assessing the general standard of workmanship.
- The laboratory must be leak-proof and able to resist the characteristics exerted by the negative pressure. Sealing specifications drawings should be made available at an early stage to eliminate faults at the test stage.
- All seals will be smoke tested and visually checked under static pressure around electrical, pipework, windows, etc. Negative pressure is also a choice when adding smoke outside the laboratory.
- The exhaust and supply ductwork is leak-tightness approved and pre-HEPA pressure is tested.
- It is also necessary to test all seals around dampers, fans, and HEPA filters, and to establish the effectiveness of the dampers in preventing reverse airflows.
- Installing engineers will also fully test and sanction every control system. This includes all controls for startup and shutdown, remote switches to the cabinet, flow adjustments, and controls for the damper, and flow adjustments.
- After installation, every HEPA filter is tested by certified engineers to ensure they meet the required specifications.
- Every alarm system is also checked, for instance for improperly opened doors, fire, electrical failure, or failure of air systems.
- Environmental control systems are also tested if possible, pieces of equipment which modify the temperature are in operation.
At Total Clean Air, our containment testing service and procedures are guaranteed to meet the top standards in the industry.
You can count on us to test, validate, and certify containment facilities to approved standards, and to make recommendations where needed.
Preparing for Pathology and Pathogen Containment Certification
From a structural point of view, pathology and pathogen containment features doors, windows, airtight walls, grills for the return air, and airtight walls. They both remove contaminants and recirculate air; therefore, exchange rates for room air and airflow are key to your containment certification.
For a low contamination environment, a correct amount of positive or negative air pressure, the correct number of air changes per hour, a controlled-access environment, and the proper amount of negative or positive air pressure are necessary.
Clean air supply through the ULPA / HEPA filters is also required. Some products have other specific conditions such as silicone, latex-free, temperature regulated, relative humidity, or more. Before full – scale service, the validation master plan will be finalised. This includes:
Approach: A design phase that elucidates the goals and outcomes to be achieved.
Protocols: They define how goals are to be achieved and cover the stage of implementation.
Analysis: It describes the test methods used to analyse the containment performance.
Total Clean Air Pathology and Pathogen Containment Certification
Total Clean Air offers comprehensive pathology and pathogen containment certification, testing and related services by ensuring:
HSE Compliance
It is important to comply with health and safety regulations. These regulations help to protect against hazardous and often tragic accidents by putting the responsibility on companies and employers to provide a healthy environment.
Directors may be held accountable individually and where this duty of responsibility is overlooked.
The key elements of a successful containment safety and health management program are:
- Adequate illumination
- Heating airflow
- Secure Workspace
- Clean Workspace
- Washing facilities
- Baths
HEPA/ULPA Filter Installation Leak Test
This testing is done to determine downflow and exhaust integrity from filter mount frames, filter housings, and HEPA / ULPA filters. The standard specifies the use of a calibrated aerosol generator and calibrated photometer to perform the test.
The test is based on determining the proper concentration of the HEPA filter polydisperse aerosol and identifying the penetration through filter housing, mounting frames or the filter.
The filter is scanned in downstream mode with the photometer and the probe kept at a speed no greater than 50 mm/s not more than 25 mm from the region that is being tested.
Total Clean Air can handle all containment testing for your facility. Our procedures are guaranteed to meet the top standards in the industry.
You can count on us to test, validate and certify containment facilities to approved standards, and to make recommendations where needed.
Comprehensive Report Writing
There are two parts to a complete containment validation report.
Part 1 is the study on classification and certification mostly collected from an external contractor. The report will describe the occupancy states wherein the testing was conducted, the eligibility requirements, and test results such as particle count, airflow visualisation, filter leak tests, and air changes per hour or air velocity.
Where possible, all calculations performed, and original data should be detailed.
The microbiological contamination levels within the lab environment will be considered in Part 2 under both dynamic and static conditions.
In addition to viable monitoring, non-viable pressure differentials and particulate levels will also be assessed within the same time frame as these important parameters can affect the level of containment contamination.
Calibration certificates, acceptance criteria to be met, testing conditions, sampling plan/map clearly showing the sampling points within the facility, test methods for each type of test, and testing performed within each area of the cleanroom, i.e. dynamic and static conditions will be attached to the final validation report for all required equipment.
The pathogen containment is now completely tested and will be controlled by a standardised sampling system to verify that it performs to the standard needed for both non-viable and viable levels of contamination.
To begin this process or obtain more information, call Total Clean Air on 01737924700 to speak to a competent person today.
Penetration Leak Testing
Penetration leak testing is a commonly used, low-cost method of inspection used in all non-porous materials to verify surface-breaking defects.
The penetrant can be applied to all ferrous and non-ferrous materials while inspection of magnetic particles is mostly used instead for its sub-surface detection capability in ferrous components.
Penetration leak testing is done to detect welding, forging and casting surface defects such as fatigue cracks, leakage in new containments, surface porosity, and hairline cracks on in-service components.
Penetration leak testing is based on capillary force, where a low surface tension liquid pierces dry and clean surface, breaking discontinuities.
Liquid may be applied by rubbing, spraying or dipping on the test component.
After allowing sufficient penetration time, a developer is applied after the excess penetrant has been removed.
Total Clean Air for a Guaranteed Secure Environment for your Critical Processes
The focus on high requirements for the condition of the pathogen and pathology containment is a crucial step in producing better results.
At Total Clean Air, we’re always improving the standard of our regulated environment requirements to protect your critical processes and the health and safety of all the persons involved.
We have extensive expertise in biocontainment programs, ensuring that the facility’s sensitive areas meet and retain quality specifications and international standards.
Our services are conducted in compliance with our standard operational procedures, which are periodically revised to ensure that they comply with the latest local and international standards.
We also provide emergency response support, reports on the quality checked report, excellent customer service and access to qualified professional services.
Call us today on 01737 924 700 for your pathogen and pathology containment installation and testing.
