The pharmaceutical industry is highly dependent on good manufacturing practices & compliance, with successful or failed batches largely dependent on the physical environment. Electrical contractors working in the UK pharmaceutical Industry, have the challenging task of designing, installing, and maintaining systems that are practically invisible in terms of hygiene risks.
At Process Control Services UK Ltd (PCS), we are well aware that each conduit, cable, control panel and associated pieces of equipment, should be expertly designed to prevent cross-contamination, and the electrical layout has to be in sync with the Contamination Control Strategy (CCS), or else the requirements of modern medicine production won’t be met.
Here are a few electrical design choices that directly impact GMP compliance in pharmaceutical facilities.
Choice 1: Flush-Mounted Hardware to Eliminate Microbial Reservoirs
You’ll want to pay close attention to the physical integration of electrical outlets and control interfaces when designing the layout of your cleanroom. Standard surface-mounted trunking poses a problem because it creates dead zones that collect dust and bacteria out of reach of cleaning, and in a cleanroom, compliance is a liability.
PCS UK Ltd takes a proactive stance on this issue, insisting on flush-mounted accessories, which either have antimicrobial bio ingredients or are constructed from stainless-steel 316L. These best working practices also cover automation, and items such as HMI screens which are considered high risk touch points, that can be installed with minimal environmental impact, antimicrobial coatings, that fit perfectly into the cleanroom wall, eliminating the problems associated with ledges and gaps. This top-quality design also makes it easier for washdown and sanitization, because these chemicals can now reach all areas of the surface. This ensures the maintenance of grade A or B environmental integrity.
Choice 2: Total Cable Segregation to Protect ALCOA+ Data Integrity
Data integrity is one of the cornerstones of GMP ensuring quality and compliance throughout the manufacturing process. If your electrical contractor is installing low & high voltage power cables in the same containment as extra low-voltage sensor cables, this is not only a potential breach of BS7671 wiring regulations, but Electromagnetic Interference (EMI) will inevitably result. Electromagnetic Interference is something that we as UK-wide electrical contracting service providers, prevent through rigorous segregation and cable route planning
EMI can produce packet losses within your monitoring system, causing gaps within your batch records. Your data, therefore, becomes non-contemporaneous and inaccurate. Our approach at PCS is to adopt separate and screened containment systems as well as clean earthing systems. Our aim here is to ensure a firm handshake within your production equipment, and the Building Management System is continually maintained.
Choice 3: Active Harmonic Filtering in Control Panels
The acquisition of BJ Control Panels has enabled PCS to hone a key design decision for incorporating Active Harmonic Filters in Motor Control Centres (MCCs). Harmonics are produced when machinery such as Pharmaceutical Electrical Equipment, centrifuges, and mixers using VSDs or switch mode power supplies pollute the power supplied to their motors along with potential disturbances in the upstream site supply.
This “dirty power” can cause sensitive lab instruments to malfunction or fail early. In building panels that incorporate filters into their design, we can provide a clean sine wave. This selection maximizes the lifespan of your calibrated equipment and prevents random resets, which are potential causes of an Out-of-Specification investigation that can take place when instruments are malfunctioning due to poor power delivery.
Choice 4: Sealing Protocols for Conduit and Penetrations
Every time a cable passes through a cleanroom wall, it represents a risk to pressure differentials within the controlled environment. A common failure we see is inadequate sealing at these points. PCS utilizes specialized, non-shedding gastight seals and transit systems. This design choice ensures that the electrical infrastructure does not compromise the pressure sensitive environment(s) required to keep contaminants out of sterile zones.
Conclusion: Engineering for Audit Readiness
Every design choice mentioned above is documented by PCS through Design Qualification (DQ) and Installation Qualification (IQ). This ensures that when an auditor asks why a specific component was chosen, you have a technical, risk-based answer ready.
Are you ready to harden your facility against compliance risks? Contact PCS to discuss a GMP-focused electrical audit or a bespoke control panel design by calling 01889 503540 or emailing PCS UK Ltd atsales@pcsukltd.co.uk.
