Temperature mapping studies - Simplifying with validation services

Nathan Roman, Genesis AEC, Director of Validation

What is the current state of how GxP industry performs temperature mapping?

Current Good Manufacturing Practice (CGMP), according to the FDA's Code of Federal Regulations Title 21, requires that environments used to manufacture or process drug products be validated to ensure a high degree of quality and efficacy.  Each firm is responsible for selecting suitable equipment used in research and development, manufacturing, or storage to produce quality products in accordance with CGMP.

Handling of equipment, calibration, maintenance, including temperature and/or humidity mapping, qualification, or validation of storage environments must be performed to ensure conditions match the stability requirements of the products. This is also a requirement as per international standards to ensure that the products are always stored and distributed within the specified temperature limits.

To ensure and demonstrate that proper environmental conditions and temperature and /or humidity controls are obtained, qualification and/or validation is expected to be carried out. Temperature Mapping studies must be carried out regularly as part of the equipment installation and operational qualification (IOQ) to ensure that an environmental room or controlled temperature chamber is capable of accurate and repeatable performance.

Temperature Mapping Studies: Equipment Qualification

A properly developed qualification protocol will help ensure that the equipment meets all documentation requirements and performs as expected, including the temperature mapping study is correctly carried out. A trusted validation service provider can work with you to determine whether your qualification protocol is sufficient or help you generate a protocol to meet your requirements.

Generally, a protocol contains a documented approach to conduct the qualification process along with the procedure, scope, equipment description, responsibilities, test method, IQ/OQ/PQ test scripts, acceptance criteria, report and approval.

Since these concepts are not entirely always clear, the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition) provides guidance on commissioning and qualification, temperature mapping, periodic reviews and also provides examples and sample templates.

Quick Guide to Mapping Protocols

Here is a list of what a basic temperature mapping protocol should contain:

Installation Qualification

– Standard Operating Procedures
– Equipment and Utility Installation Verification
– Documentation and Drawings Verification
– Calibration Status of Critical Instruments
– Test Instrument Calibration Information

Operational Qualification

– Operational Controls and Setpoint Verification
– Alarm Verification
– Empty Chamber Temperature Mapping Study
– Additional qualification tests may include (as applicable – often for reference only):
        – Open Door Verification test
        – Power Loss Temperature test

Performance Qualification

– Loaded Chamber Temperature Mapping Study
    Note: When determining mapping locations, the potential storage location should be considered. Probe locations; number of probes, distance between probes, usable space, direct path of air flow.

The goals of the qualification and mapping study’s can be summarized as:

– To demonstrate environmental uniformity for temperature and sometimes humidity
– To identify unsuitable storage locations within an area
– To determine representative monitoring points

Prior to performing a qualification or requalification on any controlled temperature unit, ensure you have all documentation required to meet the manufacturer and site requirements. It’s recommended to physically see the unit prior to starting any documentation to ensure that all the supplies/materials are all accounted for in order to meet the site requirements.

By following the steps listed above, you will be on your way to successfully completing a temperature mapping study and well prepared for your next qualification.

Vaisala Validation/Qualification Services

Vaisala Mapping Service is offered in Great Britain, Europe, and Japan.

Trusted Validation/Qualification Service Providers in America

In North Americas, these services can be provided by trusted providers in CQV who use Vaisala solutions.

“Everybody knows what needs to be done, but they’re not always sure how to get there. We know how to get there because that’s what we do, over and over again. We do things in ways that have been proven to be effective. We look at a process or system based on its objective, then we guide our clients to better solutions. Once I discovered the Vaisala data loggers and the vlog software, we saved a ton of time on mapping applications…” (Nathan Roman, Director Validation Services, Genesis AEC)

“The vLog software is extremely easy to use. The system is comparatively user friendly and much simpler than any of the other systems we’ve tried. The batch setup feature is a huge time saver when using a large number of loggers and the graphs and reports are easily configurable to meet our needs. We recently had one large pharmaceutical customer who had experienced some issues with a non-Vaisala thermal validation system. The company had concerns with the accuracy of the devices and quality of the calibrations and documentation. They made an internal decision to use only Vaisala data loggers for thermal validation.” (Neil Enlow, Principal Engineer with Performance Validation)

References:

– U.S. Pharmacopeia: Chapter 1079 Monitoring Devices – Good Storage and Shipping Practices
– MHRA: Rules and Guidance for Pharmaceutical Manufacturers and Distributors
– Health Canada (Guide-0069) Guidelines for Temperature Control of Drug Products During Storage and Transportation
– PDA Technical report no. 52- Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain
– EU European Commission Annex 15 Guide to Good Manufacturing Practices

Industry Guidelines:

There are many guidelines currently available on controlled temperature units and mapping guidelines.

– ISPE Good Practice Guide: Cold Chain Management
– ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition)
– USP Chapter 1079 Monitoring Devices – Good Storage and Shipping Practices (under revision 2011)
– USP Chapter 1118 Monitoring Devices – Time, Temperature, and Humidity
– FDA: 21 CFR 820.150 Storage
– FDA: 21 CFR 111 Current Good Manufacturing practice in Manufacturing Packaging, Labeling, or Holding Operations for Dietary Supplements
– PDA: Technical report no. 52 Guidance for Good Distribution Practices for the Pharmaceutical Supply Chain (2011)