By Chad Smith, Territory Sales Manager, Mid-Atlantic at AES Clean Technology
Cleanrooms are core pharmaceutical industry facilities that enable the effective manufacturing of sterile drug products (DPs) that bypass the human body’s natural defenses — such as those using the injectable or ophthalmic routes of delivery.
Good manufacturing practice (GMP) guidelines and strict regulatory standards dictate stringent requirements for cleanrooms to ensure they can deliver adequate sterile integrity. At the same time, though, cleanrooms must be fit for purpose, enabling manufacturers to produce the required volumes of DP efficiently while also allowing for regular maintenance.
With this in mind, taking a new cleanroom construction project from idea to reality is a multifaceted process, relying on input from diverse specialists with unique capabilities.
To ensure cleanroom success, it is vital to break the project down into three key steps and consider many factors at each stage:
At the start of a cleanroom project, having a comprehensive understanding of the DP to be manufactured in the space, as well as other project requirements, is critical to providing insight into cleanroom design needs. To accurately define the target cleanroom, it is essential to ensure that the right questions are asked at the earliest possible point of the process.
A strategic partner with specialist expertise in cleanroom design can help to prompt and guide the “define” stage. They can lessen the burden on pharmaceutical companies of assimilating all the required information and ensure that all necessary insights are collected before design. With this information and a proven design methodology, a cleanroom approach can be selected. Using the gathered knowledge, a tailored solution will consider various cleanroom options, including stick-built (built on-site using traditional building materials, such as steel), prefabricated (manufactured off-site and transported to the site for assembly) and modular (pre-engineered modules used for assembly on-site).
Some of the key information that needs to be in place before the design stage includes:
- Regulatory requirements: Being adept in the current and adaptable to future regulations as established by the GMP guidelines ensures compliance is maintained throughout the life cycle and meets the needs of a specific product, such as aseptic processing requirements for a biologic or an effective containment strategy for highly potent active pharmaceutical ingredients (HPAPIs). When opting for the quality by design (QbD) method — instilling quality into a product at every stage of manufacture — in line with the design specification, regulatory compliance is built into the cleanroom so that all drugs made within the facility follow the target market regulations and are safe for patients as a result.
- Commercial direction: Having a distinct path and understanding of the drug production steps required, taking into account the commercial depth and scope is key to understanding the needs of the project and therefore the cleanroom.
- Attention to budgetary constraints: A clear outline of the budget across the whole project provides visibility and ensures that both the budget and schedules are maintained.
With a partner on hand from early development stages, a comprehensive understanding of these aspects ensures that a cleanroom fulfills these requirements so the DP is best positioned for commercial success and is safe and effective for patients.
Once the objectives of the project and the needs of the DP have been properly defined, it is crucial to design an effective space to meet them.
Several different cleanroom design approaches can be adopted depending on the needs of the product, project and partner of choice. Conceptualized with support from a specialist partner, design specifications will consider a myriad of factors including DP characteristics, facility floor plan and operator requirements.
Having flexibility is also an important part of building a cleanroom. Even though cleanroom construction is often standardized, harnessing an architectural system and operating style that can be adapted to the needs of the customer and the product drives efficiency and performance. One option is the use of a modular approach. Utilizing pre-manufactured components constructed off-site, the modules can be seamlessly assembled at the desired location to produce a fit-for-purpose cleanroom.
An example is the AES Compass™ cleanroom program, which is a design-build strategy that features upfront process design with compliance, ensuring the client’s processes take place in a compliant facility. With a comprehensive planning and production time frame, risks are mitigated to make sure projects remain on time and on budget.
Once an effective and comprehensive design is in place, construction can begin. The successful building of the cleanroom design rests with the project team, ensuring that the cleanroom is built to the desired specifications, stays within budget and is finished on time. Careful evaluation of the project team by the pharmaceutical company when selecting a partner assures that the team has the capability, experience and capacity to meet the needs of the facility and the product.
In such a competitive market, evaluating the feasibility of a time frame and budget, sticking to it and choosing a partner to meet these needs ensures that the DP remains commercially viable when it reaches the market. Design and construction risks are mitigated by assessing the capabilities, proven experience and financial stability of a potential vendor.
With this approach, the cleanroom can be installed irrespective of building specifications while still meeting the design parameters for the required use. There is also no lag time between design and procurement, and with the ability to run multiple parallel operations, timelines to completion are accelerated.
Selecting the right partner
Meeting the “define, design and deliver” objectives hinges on selecting the best partner who can ensure that the fit and finish of the cleanroom meets the needs of the client and the patient. By considering experience, regulatory expertise and approach, a reliable and customer-focused cleanroom provider guides the client through the process.
Collaborating with a partner from the early stages enables intent, fit and purpose to be built throughout concept, design and construction. By asking the right questions to gather insight and providing the right technology and expertise, the partner can deliver on the agreed concept. Encompassing everything you need to take a cleanroom project from concept to completion, AES Clean Technology can design, construct and implement a custom cleanroom solution.
As a strategic partner, AES Clean Technology’s tailored solutions can help you define, design and deliver your next cleanroom for efficient and effective production of essential DPs to bring therapies to patients as quickly as possible. Contact our cleanroom experts today and see how we can help your organization achieve cleanroom success.