A controlled environment is critical to maintaining the potency and safety of pharmaceutical products across a supply chain stretching between R&D laboratories, manufacturing facilities, transportation and storage at healthcare facilities. Examples of controlled environments include laboratory refrigerators, laboratory freezers, blood bank refrigerators, chromatography refrigerators, laboratory incubators, stability chambers and temperature test chambers.
Equipment such as this as manufactured by Norlake Scientific and offered by Tovatech is designed and constructed to comply with standards developed and promulgated by the FDA, the AABB, the Red Cross and other agencies. Once the equipment is purchased, however, the facility operator assumes the responsibility of assuring it is installed and maintained according to FDA and related guidelines.
Equipment manufacturers play a key role in helping customers conform to these guidelines. Also important are third-party service providers such as Quality Solutions, LLC. Firms such as these offer documented validation and calibration services to satisfy initial and periodic audits by the FDA.
The Laboratory Equipment Validation Process
Before new equipment is put into operation it must pass installation qualification (IQ). As described by Quality Solutions, IQ consists of documented verification that the installation adheres to approved specifications and meets design criteria. This qualification is developed from design specifications, user requirements, drawings, equipment manuals and related documentation.
Operational qualification (OQ) provides documented verification that the equipment operates per design criteria over the defined operating ranges and defined challenges. Included are documents supporting standard operating procedures (SOP) and calibration records, the latter of which proves the equipment is performing within specified parameters. Examples of OQ testing include safety features and alarms, sequences of operation, uniformity studies relating to temperature, relative humidity, and CO2, andequipment shutdown and recovery testing. Data logs may be used to obtain minimum, maximum and average temperature of a unit, and verify that these fall within predetermined values.
Performance qualification (PQ) verifies that the equipment continues to do what it should be doing when in actual use. PQ may be scheduled at set intervals during the equipment lifetime, and includes calibration testing to insure the unit is within specification and that any out-of-spec conditions are quickly corrected. NIST (National Institute of Standards and Technology) traceable testing equipment is used to collect as-found and as-left data recorded on calibration certificates.
What procedures does your organization employ to assure equipment is installed and operated according to industry standards? How often is your controlled environment equipment recalibrated?