General Site Preparation

Facility and Service Area Access:

Arrange access to the facility and all restricted or controlled areas included in the service scope, such as cleanrooms, laboratories, mechanical rooms, equipment areas, or specialized spaces. Avoid scheduling conflicting activities or operations that could restrict access or interfere with service.

Fire Alarm System Management:

Services that generate smoke, fog, aerosol, or vapor—such as airflow visualization, HEPA filter integrity testing, and certain decontamination services—may activate facility detection systems. Before work begins, the client is responsible for coordinating with authorized facility personnel to isolate affected devices or place the applicable alarm zone or system in test mode, consistent with facility procedures and life-safety requirements. The client is also responsible for restoring the system to normal operation after service.

Garbing, PPE, and Material Handling Protocols:

Provide applicable requirements for garbing, personal protective equipment (PPE), and material ingress or egress for review before the service date. The facility is responsible for supplying site-required garbing and PPE unless alternative arrangements have been made in advance.

Equipment Readiness:

Ensure that all equipment included in the service scope is accessible and available for the full scheduled service window. Equipment should not be in active use or committed to other activities that could delay or interrupt service. Where applicable, equipment should be cleaned and cleared of products, materials, or hazards that could interfere with the work. Some services may require equipment to be empty, operating, shut down, or placed in a specific configuration; facility personnel should be available to prepare, operate, or adjust equipment as needed.

Elevated Work and Equipment Access:

Notify TSS in advance when service locations require elevated access or are obstructed by equipment, utilities, or other structures. The client is responsible for providing suitable access equipment unless other arrangements have been made in advance.

Site-Specific Access Requirements:

Notify our scheduling team in advance of any site-specific access requirements, such as mandatory training, safety sign-offs, orientation procedures, health screenings, or security clearances. Advance notice allows adequate time to address these requirements and helps prevent delays.

Availability of Key Personnel:

Ensure that necessary personnel—such as facility management, maintenance staff, equipment users or area representatives—are available on the scheduled service date. Their assistance may be needed to provide access, answer service-related questions, operate equipment or make system adjustments.

Service Specifications and Acceptance Criteria:

Provide applicable test methods, operating requirements, and acceptance criteria before the scheduled service date. For custom equipment or devices without manufacturer-provided specifications, identify the required operating configuration, test points, performance limits, and documentation requirements. TSS may be unable to complete testing or determine compliance when applicable criteria have not been established.

Changes to Scope, Criteria, or Testing Protocols:

Notify our scheduling team as early as possible of any changes to the original scope of work, acceptance criteria, or required service protocols. Advance notice supports accurate planning, staffing, equipment selection, documentation, and billing.

Special Documentation Requirements:

Notify our scheduling team in advance of any special documentation requirements, such as client-specific forms or protocol execution. Client-specific documentation is the client's responsibility unless TSS has agreed in advance to prepare or complete it.

Drawings and Facility Documentation:

Current documentation—such as floor plans, mechanical drawings, equipment records, system diagrams, or previous service reports—may be requested when needed to identify service locations, equipment, system relationships, or applicable requirements.

Post-Service Cleaning:

Some services may introduce aerosol, visualization media, dust, or other residue, or may require access above equipment and work surfaces. The client is responsible for evaluating and performing appropriate post-service cleaning before returning affected areas or equipment to normal operation.
[ return to top ]

Pharmacy (USP 797) Testing

Cleaning Before Environmental Monitoring:

Consistent with CETA CAG-009, cleaning must not be performed immediately before environmental monitoring because the results may not accurately represent conditions within the compounding suite. Cleaning may temporarily reduce surface bioburden while increasing airborne bioburden by disturbing and dispersing microorganisms. If contamination is present, it is important that it be recovered during sampling so the source can be investigated and effectively remediated.

Ceiling HEPA Filter Access:

Ensure that ceiling-mounted HEPA filters are safely accessible for integrity testing. For example, rooms with ceiling heights greater than 10 feet may require an OSHA-compliant ladder, personnel lift, or scaffolding. The client is responsible for providing suitable access equipment unless other arrangements have been made with TSS in advance. Notify TSS before the service date if fixed equipment, utilities, room configuration, or operational restrictions could obstruct filter access or prevent the use of standard access equipment. Alternative access or testing arrangements must be evaluated in advance.

Aerosol Injection Ports for HEPA Filter Integrity Testing:

Provide an accessible and suitable location for introducing the aerosol challenge upstream of each HEPA filter. Depending on the system design, this may include a room-side injection port, filter-frame port, duct-access port, or another approved upstream location. The injection arrangement must allow the required upstream aerosol concentration and distribution to be established without creating an unsafe condition or contaminating unintended areas. Notify TSS in advance when injection locations are unavailable, inaccessible, or located outside the compounding suite so alternative methods can be evaluated.

Personnel for Dynamic Testing:

Provide qualified pharmacy personnel to perform representative operational simulations during dynamic testing. Personnel may be needed during viable air sampling, total airborne particle counting, and airflow visualization studies. Simulations should reflect routine compounding activities, including typical personnel movement, equipment use, and material transfers.

Environmental Sampling Plan:

Develop and approve a facility-specific environmental sampling plan before certification and environmental monitoring. Sampling locations should be selected using a documented risk assessment that considers factors such as compounding activities, personnel and material flow, proximity to critical areas, equipment placement, room layout, and historical results. Pharmacy management should lead this process with input from TSS and other relevant vendors or subject-matter experts, as appropriate.

Airflow Adjustment Capability:

Ensure that supply and exhaust systems serving the compounding suite can be adjusted when necessary. Adjustment may be provided through balancing dampers, the Building Management System (BMS), or the Building Automation System (BAS). Appropriate facility or controls personnel should be available to make adjustments when airflow, air-change rates, or room pressure relationships do not meet the applicable criteria.

Post-Service Cleaning:

Certification activities—including HEPA filter integrity testing, airflow visualization studies, and access to ceiling-mounted components—may introduce aerosol, visualization-media residue, dust, or other contamination into the controlled environment. After certification, the client is responsible for performing applicable cleaning and disinfection of affected rooms, equipment, and surfaces in accordance with facility procedures before resuming compounding, production, or other controlled operations.

Informational: Typical Testing Sequence Existing Sterile Compounding Facilities

A typical recertification sequence is:

Viable Air and Surface Sampling
Total Airborne Particulate Counting
Supply and Exhaust Airflow Measurements
HEPA Filter Integrity Testing
Room Pressure Measurements
Airflow Visualization Studies

Newly Constructed or Renovated Sterile Compounding Facilities

A typical initial-certification sequence is:

Supply and Exhaust Airflow Measurements
HEPA Filter Integrity Testing
Room Pressure Measurements
Airflow Visualization Studies
Terminal Cleaning
Viable Air and Surface Sampling
Total Airborne Particulate Counting

The sequence may be adjusted based on facility conditions, system deficiencies, construction status, client protocols, or the need for balancing and corrective work
[ return to top ]

Cleanroom Testing

Ceiling HEPA Filter Access:

Aerosol Injection Ports for HEPA Filter Integrity Testing:

Personnel for Operational Simulations:

When operational testing is required, provide qualified personnel to perform representative activities within the cleanroom or controlled environment. Personnel may be needed during viable air sampling, total airborne particle counting, and airflow visualization studies. Simulations should reflect normal operations, including typical personnel movement, equipment use, and material transfers

Airflow Adjustment Capability:

Ensure that supply and exhaust systems serving the cleanroom or controlled environment can be adjusted when necessary. Adjustment may be provided through balancing dampers, the Building Management System (BMS), or the Building Automation System (BAS). Appropriate facility or controls personnel should be available to make adjustments when airflow, air-change rates, or room pressure relationships do not meet the applicable criteria.

Post-Service Cleaning:

Certification activities—including HEPA filter integrity testing, airflow visualization studies, and access to ceiling-mounted components—may introduce aerosol, visualization-media residue, dust, or other contamination into the controlled environment. After certification, the client is responsible for performing applicable cleaning and disinfection of affected rooms, equipment, and surfaces in accordance with facility procedures before resuming production or other controlled operations.
[ return to top ]

Airflow Visualization Study (Non-USP)

Process and Equipment Readiness:

Ensure that the study area, equipment, materials, and process setup are ready before the scheduled service. Equipment should be operating in its intended configuration, and any materials, tools, or substitutes needed to perform operational simulations should be available. Notify TSS in advance if hazardous, sterile, or product-contact activities require special controls or restrict the use of visualization media.

Personnel for Operational Simulations:

When operational simulations are included in the study, provide qualified personnel to perform representative activities. Simulations should reflect normal operations, including typical personnel movements, equipment use, material transfers, process interventions, and other activities identified in the approved study protocol.

Post-Service Cleaning:

Airflow visualization media may leave residue on equipment, work surfaces, floors, or other nearby areas. The client is responsible for performing appropriate cleaning after the study and before returning the area or equipment to normal operation. Cleaning should follow facility procedures and be compatible with the visualization medium and affected materials.
[ return to top ]

ASHRAE 110 Testing

Room Readiness and Access Control:

Ensure that the room is complete and operating in its intended configuration, with doors, walls, ceiling tiles, supply diffusers, equipment, and furnishings in place. Activities that create drafts or interfere with testing should be suspended, and access to the room may need to be restricted during tracer gas testing.

Hood and Room Air Balance:

Complete balancing of the fume hood exhaust and associated room supply and exhaust systems before testing. If the hood does not meet the specified airflow criteria and adjustments cannot be made through an accessible damper or control system, a qualified air-balancing or controls representative must be available to make adjustments. Otherwise, testing may need to be rescheduled.

Exhaust Discharge and Re-entrainment:

Fume hood exhaust should discharge in a location and manner that prevents exhaust from re-entering the building through outdoor-air intakes, windows, doors, or other openings. Suspected re-entrainment may elevate background tracer gas concentrations, compromise test results, and require testing to be discontinued until the condition is evaluated.

Cross-Drafts and Air Disturbances:

Minimize cross-drafts, downdrafts, and other air disturbances near the hood before testing. Potential sources include supply diffusers, open doors or windows, pedestrian traffic, portable fans, adjacent fume hoods, and nearby equipment. Excessive air movement near the hood face may adversely affect containment and test results.

Test Specifications:

Provide the required test configuration and acceptance criteria—such as sash position, face velocity range, tracer gas release rate, performance rating, and applicable AI or AU test condition—at least one week before the scheduled service date.

Setback-Mode Testing:

Notify TSS in advance if testing is required at a setback airflow condition. Authorized facility or controls personnel must be available to place and maintain the hood in the specified mode while testing is performed. Occupancy sensors or other controls that automatically return the hood to normal operation may require an approved override. Safety alarms or controls must not be disabled unless specifically authorized and managed in accordance with facility procedures.

Tracer Gas Leakage:

If significant tracer gas leakage is detected, testing may be paused or discontinued until the cause is evaluated and conditions are safe for testing to continue. Additional testing may require corrective action, system adjustment, or a return visit.

As-Manufactured (AM) Testing Conditions:

When As-Manufactured testing is required, the manufacturer's test laboratory must meet the applicable requirements of ASHRAE 110. This includes maintaining the test room at 0.02 in. w.c. (5 Pa) below the static pressure outside the room and limiting crosscurrents measured 1.5 feet (0.5 m) from the hood face to less than 30 fpm (0.15 m/s). The laboratory must also allow measurement of hood volumetric airflow and collar static pressure using the applicable ASHRAE methods.

The hood must discharge outside the test laboratory. Whenever possible, the exhaust fan should be located near the discharge point to keep interior ductwork under negative pressure. Positive-pressure ductwork must be adequately sealed, as leakage can release tracer gas into the laboratory and compromise testing.
[ return to top ]

Device Decontamination

Hazard Risk Assessments:

A qualified biosafety officer, Environmental Health and Safety (EH&S) representative, or other appropriate safety professional must evaluate units known or suspected to contain biological, chemical, or other hazardous agents. The decontamination method and required controls should be determined collaboratively by the unit user, facility safety personnel, and TSS. The TSS Hazard Risk Assessment Form must be completed, submitted, and approved before service.

Utility Isolation:

Before decontamination, shut off and verify all utility connections to the unit—including natural gas, oxygen, compressed air, and vacuum systems—as inactive. Whenever possible, utilities should be isolated at a remote shutoff valve. If remote isolation is unavailable, an internal valve or petcock may be used only when it has been leak-tested and confirmed to provide effective isolation. Appropriate facility personnel must perform or authorize utility isolation.

Facility Exhaust Isolation:

Units hard-ducted to the facility exhaust system must be isolated using a gas-tight damper. If suitable isolation is unavailable, the unit must be physically disconnected from the exhaust system before service. Canopy- or thimble-connected units must also be disconnected when required by the decontamination method. Qualified HVAC or sheet-metal personnel must be available to perform disconnection and reconnection as needed.

Personnel Notification and Area Restrictions:

Notify personnel in adjacent or surrounding areas—including personnel who may access nearby rooftops, mechanical spaces, or shared service areas—of the scheduled decontamination activity. Access to the decontamination area must be restricted throughout the procedure.

When secondary containment is not available, establish the exclusion zone specified by the TSS procedure and approved hazard risk assessment. This may include a minimum 20-foot perimeter around the unit or restriction of the entire non-recirculated space. Appropriate barriers and warning signage must be used to prevent unauthorized entry.

Warning Signage and Access Control:

TSS will post warning signage at the unit and all identified entrances to the affected area. Once signage and barriers are in place, no one may enter the exclusion zone except authorized personnel involved in the decontamination process.

Access will remain restricted until TSS verifies that the area meets the established clearance criteria using a monitoring method appropriate for the decontaminating agent, such as a portable gas or vapor analyzer, colorimetric indicator tubes, or an equivalent method. The client is responsible for ensuring that facility personnel understand and comply with all posted restrictions.

Emergency Communication:

Emergency contact information for the assigned TSS technician will be included on the posted signage. If an emergency occurs or the service must be interrupted, immediately contact the TSS technician and the facility's EH&S or designated emergency-response representative. Personnel must not enter the restricted area unless authorized under the applicable emergency-response procedure.

Animal Research Areas:

Remove all laboratory animals from the decontamination exclusion zone, including animals housed in other units within that zone, before service begins. Animals must remain outside the restricted area until clearance criteria have been met and the area has been released for re-entry.

Personnel Working Near Decontamination Areas:

To minimize potential exposure to personnel, decontamination services may be scheduled for weekends or overnight upon request. If the unit is located within a negative-pressure secondary containment system or an un-recirculated, negative-pressure area—with all unrelated personnel and laboratory animals removed—decontamination may proceed during regular working hours.

Garbing, PPE, and Material Handling Protocols:

Provide applicable garbing, personal protective equipment (PPE), and material ingress/egress procedures for review before technician arrival. The facility is responsible for providing PPE and garbing required for site or area access unless other arrangements have been made in advance. TSS will provide the specialized PPE required to perform the decontamination service.

Equipment and Area Preparation:

Remove all materials that are not intended to be decontaminated from the unit and affected area. This includes absorbent or agent-sensitive materials such as cardboard, tissue-wipe boxes, glove-supply boxes, and cardboard waste containers. The client is responsible for determining the compatibility of equipment and materials—such as robots, computers, laboratory instruments, and other devices—that remain in the affected area and for protecting or removing items that could be damaged.

Waste Management:

TSS may generate small amounts of nonhazardous, construction-type waste during service. This waste will be placed in facility-provided dumpsters or waste containers when permitted by facility procedures. Materials identified or suspected as hazardous will be appropriately contained and labeled by TSS, but the facility is responsible for disposal through its hazardous-waste management program.

TSS does not transport or dispose of hazardous waste off-site and does not remove or dispose of units designated for decommissioning.

Scope Limitation:

TSS evaluates and decontaminates only the equipment and systems identified in the approved scope of work. TSS makes no representation regarding the presence or absence of hazardous substances within facility exhaust systems, utilities, adjacent equipment, or other systems outside that scope.
[ return to top ]

Large Scale Decontamination

Protocol Approval:

The decontamination protocol must be reviewed and approved by both the client and TSS before mobilization. Changes to the approved protocol may affect scheduling, equipment requirements, service duration, or pricing.

Fire and Smoke-Detection Systems:

Before the decontamination process begins, the client must coordinate with authorized facility personnel to place affected alarm zones or systems in test mode and isolate, cap, or seal affected detectors as required. Alarm-system modifications must follow facility procedures and life-safety requirements. The client is responsible for restoring and verifying normal system operation after the area is released.

HVAC and Building-Control Support:

Facilities or controls personnel must be available to assist TSS with HVAC and building-control systems serving the decontamination area. Assistance may include isolating or adjusting supply, return, and exhaust systems; controlling room pressure relationships; and addressing systems serving adjoining spaces. Required system configurations will be identified in the approved protocol.

Personnel in Adjacent Areas:

Notify personnel who work in or may access adjacent rooms, corridors, mechanical spaces, rooftops, or other potentially affected areas. To minimize exposure risk and operational disruption, decontamination may be scheduled during weekends, overnight periods, or other off-hours. Work may proceed during normal operating hours only when the approved containment, pressure, access-control, and monitoring measures are in place and unrelated personnel have been removed from affected areas.

Warning Signage and Access Control:

TSS will post warning signage at identified entrances to the decontamination area. Once signage and barriers are in place, no one may enter the restricted area except authorized personnel involved in the decontamination process.

Emergency Communication:

Animal Research Areas:

Remove all laboratory animals from the decontamination area and any adjoining areas identified in the approved protocol or risk assessment. Animals must remain outside restricted areas until clearance criteria have been met and the areas have been released for re-entry.

Electrical Requirements:

Depending on the size and configuration of the decontamination area, multiple dedicated 20-amp circuits may be required. TSS will identify the required quantity, voltage, and connection locations during planning. If suitable circuits are unavailable within or near the affected area, the client must arrange an approved alternative power supply before service.

Material Compatibility:

The client must evaluate equipment, finishes, and materials within the affected area for compatibility with vaporized hydrogen peroxide (VHP). VHP exposure may affect certain paints, coatings, electronics, adhesives, metals, and other materials. Items that are incompatible or of uncertain compatibility should be removed or appropriately protected before service.

Equipment and Area Preparation:

Water Sources and Standing Water:

Eliminate standing water, active leaks, and unnecessary running-water sources within the decontamination area before setup begins. Notify TSS in advance of drains, sinks, safety showers, eyewash stations, humidifiers, or other water sources that cannot be isolated.

Environmental Conditions:

VHP distribution and decontamination effectiveness depend on factors including temperature, relative humidity, agent concentration, exposure time, room volume, and material load. Unless otherwise specified in the approved protocol, affected spaces must be maintained between 60°F and 80°F during setup and decontamination, with stable conditions established before service. The starting relative humidity must be below 40%, and TSS will control process conditions as required by the approved protocol.

Biological and Chemical Indicators:

Biological indicators (BIs) and chemical indicators (CIs) will be placed throughout the decontamination area in accordance with the approved protocol. Quantity and placement will consider room layout, volume, airflow, equipment, material load, and locations that may be difficult for the agent to reach. The client may identify required or process-critical locations before the service date; otherwise, TSS will select representative and worst-case locations.

Waste Management:

TSS does not transport or dispose of hazardous waste off-site and does not remove or dispose of units designated for decommissioning.

Scope Limitation:

TSS evaluates and decontaminates only the rooms, equipment, and systems identified in the approved scope and protocol. TSS makes no representation regarding the presence or absence of hazardous substances in adjoining spaces, external facility systems, or other areas outside that scope.
[ return to top ]

Compressed Air/Gas (CDA)

System Readiness:

Ensure that the compressed air or gas system is operating and available for the full scheduled service window, including applicable compressors and inline dryers. All point-of-use lines associated with the system under test should not be used during testing. All inline and point-of-use filters included in the normal operating configuration must be installed before TSS arrives. When required by the test method or facility procedure, purge or blow down the lines before testing.

Test-Point Access and Disconnection:

Ensure that each test point is accessible and available for testing. Notify TSS in advance if equipment, tubing, regulators, or other connections must be removed to access a test point. Qualified client personnel must be available to disconnect and reconnect components that TSS is not authorized to remove.

Test-Point Location and Ventilation:

Notify TSS in advance of test points located in small, enclosed, poorly ventilated, or potentially oxygen-deficient areas. The facility must evaluate these locations and provide any required ventilation, atmospheric monitoring, access controls, or confined-space procedures. Testing may be delayed or discontinued if the location cannot be accessed safely.

Line Pressure:

Unless otherwise arranged in advance, test points must provide at least 50 psig during sampling. Notify TSS before service if the available pressure is below 50 psig or may decrease while the line is flowing. Insufficient pressure may prevent completion of testing and result in delays, a return visit, or additional charges.

Tank-Fed Gas Systems:

Ensure that an adequate supply of gas is available to complete testing. Required volume depends on the number of test points, analyses performed, sampling flow rates, and test duration. Notify TSS in advance when gas availability is limited or cylinder replacement may be required during service.

Connection Types:

Provide the connection type at each test point before service, including thread type and size or the manufacturer and model of any quick-disconnect fitting. Unidentified or incompatible connections may prevent sampling or require a return visit.

Testing Requirements and Acceptance Criteria:

Provide the applicable standard, test methods, and acceptance criteria before service so TSS can select the appropriate sampling equipment and laboratory analyses. Depending on the system and intended use, required criteria may include:

Viable microbial limits, including aerobic or anaerobic analysis
Nonviable particle limits or ISO 8573 particle class
Oil aerosol or total hydrocarbon limits
Moisture or dew-point requirements, including whether pressure dew point or atmospheric dew point applies
Gas identity, purity, or concentration requirements
Other client- or process-specific requirements

Gross Contamination Screening:

TSS will perform an initial screening for visible moisture, oil, debris, or other gross contamination before analytical sampling. If gross contamination is observed, further testing may be discontinued to protect sampling equipment and prevent results that are not representative of normal system performance. Corrective action and a return visit may be required.

Expedited Laboratory Results:

Request expedited oil, hydrocarbon, purity, or other laboratory results before the scheduled service date. Expedited turnaround is subject to laboratory availability and may require additional charges.
[ return to top ]

Equipment Certification, Calibration and/or Maintenance

Specifications for Custom Equipment:

Provide applicable test methods, operating requirements, and acceptance criteria for custom equipment or devices that do not have manufacturer-provided specifications. This information must be submitted to TSS before the scheduled service date and should identify the required operating configuration, test points, performance limits, and any client-specific documentation requirements. TSS may be unable to evaluate or certify equipment when applicable criteria have not been established.

Airflow Adjustment Capability:

When airflow testing or adjustment is included in the service scope, ensure that equipment connected to facility supply or exhaust systems can be adjusted as needed. Adjustment may be provided through equipment controls, balancing dampers, the Building Management System (BMS), or the Building Automation System (BAS). Appropriate facility or controls personnel should be available to authorize and make adjustments when the equipment does not meet the applicable airflow or pressure criteria.
[ return to top ]

Viable - Self-Serve Sampling

Kit Condition and Deviations:

Inspect the kit promptly upon receipt. If packaging is damaged, media are missing or compromised, seals are broken, contents are incorrect, or another deviation is identified, email samplingkits@techsafety.com immediately. Do not use affected materials unless directed by TSS; replacement arrangements should be completed before the scheduled sampling date.

Sampling and Kit Return:

Complete sampling and ship the kit back to TSS within 30 days of receiving it. Kits not returned within 30 days will be invoiced at the full kit cost.

Kit Shipping and Return Delivery:

Kits are shipped by FedEx Overnight at the beginning of the scheduled sampling week and include a pre-addressed return air waybill. Schedule return delivery for Monday through Friday. If Saturday delivery is required, email samplingkits@techsafety.com by Thursday of that week to confirm availability and arrangements.

Laboratory Turnaround Time:

Laboratory results, including colony counts and applicable organism identification, are generally issued within:

10-12 business days for single-media sampling with dual incubation
7-9 business days for dual-media sampling with single incubation

Turnaround time begins when the laboratory receives the samples and may vary when additional testing or investigation is required.