Proper Calibration for Successful Qualification

Why does calibration matter? If the equipment has a current calibration certificate and calibration stickerth then we can check that off and we are on our way. Well maybe? Too often we overlook a key component for a successful qualification. Proper calibration starts with the manufacturer’s design and operation of the equipment. We purchase equipment for GMP use and fast track the qualification to meet the project deadline. The service manual usually provides a calibration method based on the design and operation of the equipment. In our expedience we sometimes neglect details that we may consider mundane and jump right to our one size fits all method of calibration for related equipment, calibrate and assume success.

 Let’s first understand that if equipment passes calibration it only proves that it maintained its calibrated state since the last calibration. It does not guarantee the next day that it is still in calibration. So, calibrating prior to qualification may be beneficial.

 Several years ago I was calibrating three new GMP Freezers for a client prior to qualifying them. Our calibration SOP stated to place the calibration temperature test probe in the center of the chamber or adjacent to the controlling probe of the unit, as prescribed by the manufacturer. manualThe service manual clearly stated that the unit be calibrated to the center of the chamber. It just so happened that the client had their calibration contractor performing “6 month” calibrations on the existing identical freezers in the lab. I curiously asked the technician where in the chamber he was placing the calibration temperature test probe. His answer was that they always place the test probe adjacent to the unit’s controlling probe. The controlling probe for these freezers were located in the back right hand side corner of the middle shelf. This location also happens to be the coldest point in the unit. With a quick demonstration the client was able to see that there was almost a 2° C difference in the recorded temperature in the center of the chamber versus the temperature reading with the calibration temperature test probe placed adjacent to the controlling probe. The client’s SOP stated to place the calibration temperature test probe adjacent to the controlling probe of the unit and directed that the three new units be calibrated as such due to the project time constraint and not being able to revise the calibration SOP in time. Our demonstration proved almost a 2° C difference and by calibrating to the coldest point in the unit would jeopardize the acceptance criteria temperature span on the warm side. The first two brand new freezers failed qualification and could not maintain temperature criteria. The warmest locations in the freezer were more than 10° C less than the required set-how-to-draw-a-thermometerpoint. The devastated client quickly revised their calibration SOP and re-calibrated to the center of the chamber with all three new freezers then able to pass qualification.

It is always beneficial to double-check an equipment manual when performing a calibration, even is there is an established procedure in place and you are familiar and comfortable with a certain process.  SOPs are often written based on previous practices and may not take new equipment models and locations of sensors into consideration.   Verifying the proper set of instructions insures the proper calibration the first time and in the long run will save time and frustration.

 

Written By: Jim Scearbo, Senior Consultant

ICQ Consultants, Corp.

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ICQ Consultants is looking to hire top talent

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ICQ Consultants is looking to hire dedicated professionals in the MA, NC, NJ and PA areas. ICQ is one of the largest and most sought after CQV suppliers in the Northeast and we have expanded with offices in the Southeast as well. We are seeking to hire mid to senior level Validation staff.

Integrated Commissioning & Qualification, supplies services in the life science industry. In addition to offering commissioning and qualification services, we also offer QA, QC, Engineering, PV, PM and technical writing staff.

We focus on the commissioning effort in alignment with qualification, which can leverage many aspects of those efforts with complying to procedures and quality systems.

Our company provides some of the most competitive benefits and wages in our segment of service provider which include the following:

  • Tufts Health Insurance, Dental and Vision Plans – Paid 100% by ICQ
  • Short Term / Long Term Disability – Paid 100% by ICQ
  • Life Insurance – Paid 100% by ICQ
  • Paid Time off for Holidays, Sick Time and Vacation
  • 401 K with a 100% match to the first 4%

GENERAL RESPONSIBILITIES AND REPORTING/EDUCATION/EXPERIENCE
REQUIREMENTS

These positions report to the assigned manager and have responsibilities for development and execution of commissioning and qualification protocols, including test functions, and sampling.  Employee must always be compliant with the company’s Standard Operating Procedures and policies. Adherence to timelines and deliverables are a must.  Experience or a demonstrated ability to perform the responsibilities of the position in leading, planning, and execution of projects involving one or more of the following:

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  • 5 to 7 years’ experience in Cleaning Validation and/or Sterilization
  • 5 to 7 years’ experience in Environmental Monitoring
  • 5 to 7 years’ experience in Commissioning, Qualification and Validation of Utilities, Facilities, Processes and Process Equipment

 

RESPONSIBILITIES:

  • Knowledge of FDA requirements, including cGMP’s, Quality System Remediation and Quality by Design, ICH-Q9, ICH-Q10, ASTM E-2500 principles.
  • BS/BA degree in Biology, Biochemistry, Chemistry, Engineering or related experience in FDA-regulated industries working in QC, Manufacturing, Engineering, QA and/or Validation.
  • Develop and execute commissioning/validation plans, test plans, validation protocols/reports and procedures.
  • Customarily and regularly exercises discretionary powers and independent judgment in performing the job.
  • Work as a leader, part of commissioning/validation team, or independently to develop protocols and procedures, execute same including test functions, sampling and calibration.
  • Responsible for developing new business opportunities at assigned client sites.
  • Communication with management, clients, and project team members.
  • Participate in training to ensure continued accreditation.
  • Other tasks as required by department management.
  • Travel may be required.
  • Research and interpret client and vendor-supplied documentation in order to write documents.

OTHER DESIRED SKILLS AND EXPERIENCE

  • Process Validation
  • Sterilization / Autoclave Performance Qualification
  • Quality Systems and Remediation
  • Implementation of Quality by Design
  • Packaging Line Validation
  • Cleaning Validation
  • QC Lab Commissioning/Qualification/Validation
  • Commissioning, Qualification and Validation Generalist (Facilities, Utilities, Process Equipment etc.)
  • Strong Attention to Detail
  • Proficient in MS Word and MS Excel
  • Excellent Communication Skills
  • Ability to handle many tasks with limited direction
  • Ability to deliver results is a must
  • Demonstrated interest in continued professional development
  • Demonstrated interest to provide a high level of customer support
  • Primavera Scheduler
  • CQV Project Managers

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