Cycle Development, OQ and PQ for STERIS Autoclave
The Scope of work included the development of IOQ and PQ protocols, routing protocols to obtain required approvals, execution of IOQ and PQ and develop summary reports for new STERIS autoclaves in the PF building. Execution included empty chamber temperature mapping, OQ and temperature conformity verification, using a Kaye Validator 2000. Execution also included cycle development and data analysis of biological indicators and Fo calculations to ensure the cycle met requirements.
The scope of work required pre-verification of all lab equipment operations and accuracy prior to relocation of HPLC’s, GC’s, balances, etc., total of 225 existing pieces and 135 new. Once all existing equipment was placed within the assigned new lab areas equipment was post verified for accuracy and received full IOQ. PharmaMatrix prepared all IOQ protocols, was responsible for routing and approval with the customer. Execution schedules were prepared and managed by PharmaMatrix during the project. Weekly meetings were scheduled and managed by PharmaMatrix, bi-weekly reports were provided to the customer for record of progress. Reports outlined request where assistance was needed by others, delays, deviations, completion progress and execution status.
Environmental Chamber Mapping
The scope of work required PharmaMatrix to ensure the equipment was calibrated to manufactures specification, provide environmental mapping equipment, prepare IOQ protocol, execute and prepare the final summary. Mapping included monitoring of temperature and humidity for a 24-hour period at Static conditions and another 24 hours at Dynamic conditions. Testing included open door data to determine how long the unit is open before failure of limits is observed and total time for temperature and humidity recovery back to acceptable set point.
Assessed all data and summarized in a Final Report. Responsible for obtaining all approval signatures from customer for pre- and post-execution and for approval of the Final Report.
The scope of work required the preparation and execution of an IOQ protocol to capture the environmental conditions of a 750,000 sq. ft. warehouse. PharmaMatrix prepared an IOQ to utilize an RF wireless system that provided real-time data to the customer to observe during mapping activities. Duties included assessment of requirements, develop and execute IOQ and preparation of Final Reports. This customer has distribution warehouses through the USA and PharmaMatrix has temperature mapped all their distribution centers east of the Mississippi. Mapping has been performed for winter and summer seasons and also when approved changes to the sites rack locations and when modifications have occurred to the HVAC system.
Building Automation System Validation
The Scope of Work involved preparing Functional Specifications, Preventative Maintenance SOPs, Operational SOPs and creating an access level requirement, preparing IOQ protocols, executing protocols, preparing the Final Summary and managing the project relating to a SIEMENS Building Automation System (BAS). The customer used the SIEMENS BAS to control all air handlers, control clean space airlock doors, alarms, external email notifications and external text messaging. During the project it was noted that many of the graphics were not consistent and were also incorrect, PharmaMatrix revised all graphics to customer approval. During the project, many revisions were made to the programming of the system by PharmaMatrix to allow for better control of each room’s environment. One major change was to disable humidity alarms when a rise in humidity occurred during room cleaning. Studies were performed to determine the rise curve and when to disable the humidity alarms to prevent nuisance alarms when cleaning occurred. The change was to also address re-enabling the alarm when the room was back within its allowed limits for a period of time. Once the program changes were made the disabling and re-enabling the alarms were tested and found to meet the customers’ expectations and the satisfaction of PharmaMatrix.
All changes were captured through the customers change control program and captured in the FRS and IOQ protocols. All IOQ protocols were executed once all changes were made. The Final Report was prepared and all documentation was approved by the customer in a timely manner.