Jeff Bredeson
|
In the ever-changing world of pharmaceutical facilities delivery, there appears to be a growing interest in the utilization
of programmable logic controller (PLC) technology and process systems to control HVAC applications.
Background InformationUntil recently, HVAC equipment and building management systems (BMS) were thought of primarily as non-impact or indirect impact
systems to most regulated facility owners. The last decade or so has truly marked the evolution of quality management in the
life sciences industry. Companies, as well as the various regulatory agencies (FDA, HPB, MCA, etc.), have realized that there
is a direct link between the temperature, humidity, pressure, or particulate count in a space and the quality of the product
being manufactured, studied, manipulated, or stored in that space. The logic is that an excursion of these variables caused
by a malfunction of the system controlling these points of data — the BMS system — has "direct impact" on product quality,
and, therefore, these systems should be qualified and must pass regulatory muster. As companies are starting to embrace a
risk-based approach to validation and to assess systems and component criticality, they are finding the environment is an
important part of the quality equation in a regulated facility.
Now that the criticality of these systems is recognized, the discussion turns to finding the right control solutions for regulated
environments. Historically, commercial BMS systems, the same systems used in schools, office buildings, and hospitals, were
utilized in critical industrial areas. Today, many BMS manufacturers are improving, hardening, and securing these systems
to make them more industrial in appearance and operation. At the same time, some owners of regulated facilities are looking
at other ways to meet their needs. One of the solutions being explored and tested is applying programmable logic controller
(PLC) technology to HVAC applications. This article identifies and compares the advantages of each approach from a pragmatic
perspective.
Before the advantages of each system are individually addressed, let's examine the critical issues more closely from the building
owner's perspective.
Companies now view facility automation systems and component criticality as part of the quality equation.
|
Risk Mitigation and ComplianceRisk mitigation and compliance are critical because the penalty for non-compliance is so great, as many companies are learning.
The ability to procure robust technology that enables the attainment and maintenance of compliance is not just "nice to have;"
rather, it is the proverbial "ticket to the dance." Companies must have a product that can be applied with compliance in mind
and meet the relevant regulations — Title 21 CFR Part 210, 211, 820, and 58, as well as Title 21 CFR Part 11. From a system
purchaser's perspective, there are several considerations. First, is the vendor's solution compliant? Further, is the validation
process in line with company standards and procedures? Is there precedence of the solution being validated? Finally, is the
cost of compliance within reason?
Many system providers claim that their products are compliant with FDA regulations. In reality, when it comes to systems that
include hardware and software, compliance must be built into the product to assure the result. There are very few off-the-shelf
systems that are compliant out of the box. In fact, compliance always includes some level of procedural action on the part
of the owner. This fact stresses the need to work with a solution provider (PLC or BMS) that understands the regulations that
apply to their area of the facility and can provide references of successfully validated solutions. If you are asking a solution
provider to apply a technology to an area of the facility that is not their core competency, then you are asking for an unpredictable
outcome.
