Operating Theatres

Guidelines for testing of operating theatres can be found in "Design Guidelines - Environmental Conditions in Operating Theatres" which was published in January 1989 by the Technical Services section of WORKS. In this document, operating theatres are grouped into 3 categories according to the type of surgery and thus assigned a cleanroom class:

Type of Surgery	Cleanroom Description
Critical infection-risk surgery including: transplantation open heart insertion of orthopaedic prosthesis neurosurgery plastic surgery	Class 3.5 Laminar Airflow cleanroom
Major surgery and intensive care	Class 350 Non-laminar Airflow cleanroom
Minor surgery with no major invasion risk	Class 3500 Non-laminar Airflow cleanroom with HEPA filtration

Cleanrooms in New Zealand are covered by Australian standard AS 1386 which define the classes of cleanroom and also the performance testing required.

Some functions of an operating theatre differ from an industrial cleanroom, and some of the specifications and test requirements should be modified. The Ministry of Health are presently working on a set of ventilation requirements which will define the testing required for operating theatres in New Zealand.

Sterile prep rooms should be tested to the same cleanroom class as the theatre.

Total Air Care Laboratory offers a testing and validation service for all classes of operating theatre.

Customised Testing
The following standard testing performed by Total Air Care is based on AS 1386 modified for an operating theatre and can be taken as a guide where no testing and maintenance procedures are prescribed. Total Air Care will readily adapt its standard test procedure by removing some of the tests or adding some of the optional tests to produce a customised test procedure for a particular facility.

Standard Service
The standard annual service offered includes the following:

1. Testing Essential Performance Requirements
AS1386, the Australasian standard for cleanrooms and clean workstations requires certification of a cleanroom at least every 12 months and recommends regular maintenance every 3 months. Total Air Care Laboratory provides annual testing and certification using Australasian standard test methods to ensure that an operating theatre is performing within the essential performance requirements of the applicable standards.

The essential annual tests performed are as follows:

For Laminar Flow Theatres:

2. Immediate Communication of Problems
The test technician will communicate information regarding any problem associated with the operating theatre immediately following testing or as soon as possible.

3. Endorsed Test Report
A detailed report on each operating theatre and sterile prep room tested will usually be completed and mailed within 10 working days of completing the testing. The test report lists all the tests performed and the results obtained. The laboratory’s accreditation by International Accreditation New Zealand is clearly shown on the test report.

4. Endorsed Certificate of Compliance
A certificate of compliance is mailed with the test report for complying facilities.

5. Courteous and Professional Service
You can expect our test laboratory staff to conduct themselves in a courteous and professional manner. If you have any complaints please advise us so we can take corrective action.

6. Validation Reminder
Your operating theatre details will be loaded into our computer data base and we will automatically contact you before your facility becomes due for the next validation.

Optional Services
A number of other tests may be required. The following tests are common:

Noise level
Illuminance
Full Temperature Test (measurements over room)
Full Humidity Test (measurements over room)
Integrity of HEPA filters terminally mounted - AS 1807.6
The following tests are less common:

Performance of laminar flow cleanrooms under loaded filter conditions - AS 1807.4
Integrity of HEPA filter installations not terminally mounted - AS 1807.7
Air flow parallelism - AS 1807.11
Vibration - AS 1807.17
The test of HEPA filter integrity should be performed in the following circumstances:

If particle counting results make the integrity suspect.
If the filter is noticeably damaged.
If a new filter is installed or a damaged filter is repaired.
Maintenance
Total Air Care technicians are skilled in balancing all categories of cleanrooms and detecting and repairing system leaks. Often this can be done at the time of the testing to minimise costs.

Total Air Care carries most filters and a range of blowers in stock so we can provide fast and efficient service to minimise downtime.

Abbreviated Quarterly Testing
A reduced 3 monthly (or 6 monthly) test is designed as an input to the regular maintenance recommended.

The standard quarterly testing includes air cleanness testing with a particle counter and a check of the air pressure differentials.

Theatre Audit
If an operating theatre has not been tested regularly, a theatre audit is designed to provide a quantifiable measurement of the theatre's performance. Thus hard data is produced which is often required for management decisions regarding the theatre.

The audit involves the following steps:

Gathering of basic design information.
Measurement of air cleanness with a particle counter by AS 1807.8.
Determination of air pressure differentials by AS 1807.10.
Determination of air changes per hour.
Check of air direction above the operating table.
Measurement of temperature and relative humidi
The report that follows will indicate the actual performance of the theatre and the cleanroom class at which the system is capable of operating. Attached to the report will be suggested solutions to problems or deficiencies detected.