A world leader

A world leader in pharmaceuticals contacted Honeyman Group to provide a solution for upgrading an aged autoclave and dry heat oven.  The equipment was in good mechanical order but the controls, instrumentation and ancillary equipment were becoming unreliable, unsupportable and not regulatory compliant (control system validation and data integrity).

The pharmaceutical company had 3 problems; Time, Upheaval and Cost.

1.      Time:

The pharmaceutical company had looked into replacing the autoclave and oven with new.  The complete project timescale for replacing the existing autoclave and oven, from order placement to end of validation would be in the region of 14 months.  In addition, the actual outage time for removing the existing autoclave and oven, replacing with new equipment, rebuilding the clean room etc would be a minimum of 3 months.  Production lost for this amount of time would be completely unacceptable.

2.      Upheaval:

The autoclave was situated in a class 10,000 sterile environment.  To remove the autoclave and oven from their existing location, with new walls, offices, built around the autoclave since its original installation, would be a mammoth job.  The area would become non-sterile and production could not start again until the area was fully rebuilt, finished and validated.

3.      Cost:

The total cost of the project to replace the existing autoclave and oven, including all of the building works and other validation implications would be in the region of £500k, not to mention the sales/production impact of such a project.

Honeyman were approached to provide a solution to overcome these problems.  The first challenge was to assess the autoclave and oven for their condition, mechanics and future reliability.  The old machines had very good chambers and mechanics but the control systems and instrumentation were fast becoming unsupportable and would dictate the life of the machines.

The solution was to provide a new, modern control system with updated instrumentation.  Also to fully refurbish the plant room areas in terms of cabling, pneumatics and overall system documentation (FDS, SDS, drawings etc).

From start to finish, Honeyman Group managed the project, liaising with the Client's Quality, Engineering and Process departments logging all comments and requirements and keeping all informed of the progress of the project.

Following a full survey of the autoclave and oven, which included physical data and functional performance, Honeyman Group produced a new Functional Design Specification (FDS) for both the autoclave and oven.   The new control system developed to meet this FDS was based upon a Eurotherm T800 visual supervisor and a T2550 controller.

By choosing to upgrade only the parts of the equipment that required upgrading this minimised the disruption to the area.  The shutdown period from removal of the redundant equipment through to completing the engineering validation (IQ and OQ) on both the oven and the autoclave in parallel took only 4 weeks and the cost was significantly lower than the cost for a replacement autoclave and oven.  All documentation was handed over within 2 weeks of completion.

The client was left with a fully documented, validated autoclave with an up to date control system developed using the GAMP4 guidance and taking account of the requirements of 21 CFR part 11 for data integrity and tracking changes.