From High-Purity Water to Custom Formulations

Introduction: High-Purity Water and Custom Liquid Manufacturing

00:12–03:21

The webinar introduces ILC Dover’s growing capabilities in high-purity water, liquid formulation and contract manufacturing for life sciences. The presentation explains how customer requirements can begin with something as specific as WFI-quality water or develop from a larger formulation challenge, manufacturing capacity constraint or need for an external manufacturing partner.

ILC Dover’s goal is to provide flexible manufacturing solutions that help pharmaceutical, biopharmaceutical, medical device and diagnostic manufacturers reduce operational complexity, maintain product quality and move products toward commercialization efficiently.

Key takeaway: WFI-quality water is only the starting point. The broader strategy extends into custom liquid formulation, filling, packaging and manufacturing support.

Market Trends Driving Demand for High-Purity Process Liquids

03:29–06:02

Growth in biologics and advanced therapies is increasing demand for buffers, media and other high-purity process liquids. These applications can also be particularly sensitive to contamination and process variability, making consistency increasingly important.

At the same time, manufacturers face limitations in available production and cleanroom capacity. Maintaining internal high-purity water systems requires monitoring, maintenance, validation, testing, documentation and specialist expertise. Cleanroom space dedicated to supporting these activities is also space that cannot be used for core production.

These challenges become more significant as products move from development toward commercial manufacturing, when production volumes increase, quality requirements become more demanding and supply continuity becomes more important.

Key takeaway: Capacity constraints, growing quality requirements and the operational cost of producing process liquids internally are contributing to increased interest in specialized contract manufacturing.

Why Pharmaceutical Water Quality Matters

06:15–11:43

Water quality can directly affect manufacturing reliability, product quality and patient safety. A water-system failure can result in production delays, additional testing and potentially rejected or reworked batches.

The webinar introduces the concept of the Cost of Poor Quality (COPQ) and notes that these problems can consume manufacturing time, laboratory resources and equipment capacity. In some cases cited during the presentation, the cost of poor quality could represent 10–25% of an organization's total sales revenue.

An important point is that manufacturers should select water based on its intended use and associated risk. Lower-purity water may be suitable for certain upstream activities, while applications associated with parenteral products may demand much stricter microbial and endotoxin controls.

The webinar reinforces this through examples involving microbial excursions, inadequate investigation of water-system problems and the use of water that did not meet applicable USP or pharmacopeial requirements.

Key takeaway: Pharmaceutical water should always be fit for purpose. Selecting the correct water grade requires understanding the application, process and potential risk to the final product or patient.

Why Outsource WFI and High-Purity Liquid Manufacturing?

11:50–14:00

Outsourcing Water for Injection (WFI) and high-purity liquid manufacturing can help companies preserve valuable internal production capacity. Instead of allocating cleanroom space and capital to additional water-production infrastructure, manufacturers can use specialized external capabilities.

Producing high-purity liquids requires equipment, trained personnel, monitoring programs and established quality systems. External manufacturing can also provide additional flexibility when demand changes as programs expand or new products move toward commercialization.

The webinar positions outsourcing as a way to potentially reduce facility investment and operational burden while accelerating project timelines and supporting longer-term supply continuity.

Key takeaway: Outsourcing high-purity water and liquid manufacturing allows pharmaceutical companies to focus internal resources on core manufacturing activities while accessing specialized infrastructure and scalable capacity.

ILC Dover’s Life Sciences Manufacturing Facility in Lillington

14:32–16:02

ILC Dover’s new manufacturing facility in Lillington, North Carolina provides the infrastructure behind these expanded capabilities.

The approximately 65,000-square-foot facility includes three ISO Class 7 cleanrooms, ISO Class 5 Restricted Access Barrier Systems (RABS) for aseptic filling, an on-site analytical laboratory, engineering resources for validation and scale-up, and temperature-controlled warehousing.

The webinar states that the facility operates under ISO 9001 and ISO 13485 quality systems, is FDA registered and complies with 21 CFR 820.

Key takeaway: The Lillington facility has been designed to support controlled liquid manufacturing from development and scale-up through established commercial programs.

Understanding Pharmaceutical Water Grades

16:12–18:05

Not all pharmaceutical water has the same specifications or intended use. The webinar explains the differences between Purified Water, WFI-quality water, Water for Injection and Sterile Water.

Purified Water is used in appropriate non-sterile manufacturing applications and is controlled for characteristics including conductivity and Total Organic Carbon (TOC). WFI-quality water provides tighter controls and low-endotoxin performance for applications such as buffers, reagents, diagnostics, cell-culture media and medical-device manufacturing.

Water for Injection requires stricter microbiological and endotoxin controls for parenteral applications, while sterile packaged water has additional requirements associated with its intended use.

Key takeaway: Manufacturers should choose a pharmaceutical water grade according to its intended application rather than treating all high-purity water as interchangeable.

WFI-Quality Water: Production and Applications

18:12–20:32

ILC Dover describes its WFI-quality water as ultrapure, low-endotoxin water intended for processes where a high-quality water source is needed before final-product sterile filtration.

The manufacturing process described in the webinar begins with potable water and incorporates reverse osmosis, deionization, steam distillation and hot-loop circulation. During filling, the water passes through a 0.2-micron sterile filter. The resulting product is characterized by low endotoxin, low bioburden, low conductivity and low Total Organic Carbon.

Applications span biopharmaceutical manufacturing, diagnostics and medical devices. Examples include buffer and cell-culture media preparation, diagnostic reagents, assay solutions, instrument fluids, cleaning solutions, process liquids and device-associated reagents.

Key takeaway: Externally supplied WFI-quality water gives manufacturers access to a controlled, high-purity process input without necessarily maintaining equivalent water-generation infrastructure internally.

WFI Packaging and Supply Flexibility

20:39–21:45

Different manufacturing processes require different water volumes and packaging configurations. Standard formats discussed in the webinar include 1 L and 4 L bottles, 10 L single-use bags and 200 L bag-and-drum systems.

ILC Dover is also expanding toward larger-volume solutions, including 20 L single-use bags and 1,000 L rigid or collapsible IBC systems. Custom packaging can be evaluated depending on manufacturing and supply-chain requirements.

Key takeaway: Flexible packaging enables WFI-quality water supply to support different manufacturing scales and process requirements.

From WFI to Custom Formulation and Bioprocessing Solutions

21:53–24:12

One of the webinar’s most important messages is that WFI-quality water represents the beginning of a broader liquid manufacturing strategy.

ILC Dover’s facility has been designed to support non-API liquid manufacturing, including hydrated buffers, process solutions, media hydration, cell-culture feeds, cleaning solutions and other specialized liquids.

For bioprocessing applications, potential projects include upstream process buffers, downstream purification buffers, cell-culture media hydration and custom bioprocessing reagents. Supporting these products requires more than ingredient mixing. It also requires controlled environments, established manufacturing procedures, quality oversight and reliable process execution.

By combining internal WFI-quality water production with formulation, hydration, sterile filtration and aseptic filling, ILC Dover aims to reduce the need for customers to coordinate several different suppliers.

Key takeaway: The strategic proposition moves from high-purity water into integrated custom liquid manufacturing, allowing more manufacturing steps to be consolidated under one partner.

Medical Device and Diagnostic Liquid Manufacturing

24:20–25:34

The same manufacturing platform can support high-purity liquid requirements in the medical device and diagnostics industries.

For medical devices, examples discussed include device-integrated fluids, OEM process fluids, cleaning solutions and projects associated with 510(k) pathways. ILC Dover highlights capabilities including custom packaging, aseptic filling and scale-up support within controlled ISO Class 7 manufacturing environments.

Diagnostic applications can include instrument reagents, diagnostic-system fluids, diluents and customer-owned formulations.

Key takeaway: ILC Dover’s high-purity liquid manufacturing capabilities extend beyond biopharma into medical device and diagnostic applications requiring consistent, controlled manufacturing.

From Project Discovery to Commercial Manufacturing

25:46–27:11

Customer projects typically begin with a discovery phase to understand the product, application, manufacturing requirements and overall project goals.

Technical teams then evaluate feasibility before developing a proposal defining project scope, timelines, validation requirements and commercial considerations. If validation is required, a qualified manufacturing process is established before commercial release.

The project can then transition into routine manufacturing, with additional support available for inventory management, warehousing and fulfillment.

Key takeaway: The engagement model is designed to support customers from initial manufacturing discussions through validation and commercialization.

Quality, Flexibility, Scalability and Integrated Manufacturing

27:22–28:48

The webinar summarizes ILC Dover’s contract manufacturing proposition around four main principles: quality, flexibility, scalability and integrated solutions.

Strong quality systems, controlled environments, testing and documentation provide the foundation. Flexibility allows manufacturing and packaging requirements to be adapted to individual programs, while scalability creates a pathway from small batches to larger commercial production.

Integration brings these capabilities together. WFI-quality water production, formulation, filling, packaging, warehousing and fulfillment can potentially be consolidated within a single manufacturing relationship.

Key takeaway: The primary value proposition is not one individual manufacturing capability, but the ability to combine multiple stages of liquid manufacturing under one partner.

Which Projects Are a Good Fit?

28:56–30:08

The webinar closes by highlighting projects involving WFI-quality water, WFI-based formulations, buffer hydration, media hydration, diagnostic reagents and other high-quality liquid products requiring controlled manufacturing environments.

The broader vision is to support projects of different sizes as they develop from an initial requirement into scalable manufacturing programs.

Key takeaway: ILC Dover positions WFI-quality water as the foundation of a broader partnership spanning formulation and controlled liquid manufacturing through commercialization.

The central message of the webinar is the transition from high-purity water supply to integrated liquid manufacturing. WFI-quality water provides the foundation, but ILC Dover’s broader strategy includes formulation, media and buffer hydration, sterile filtration, aseptic filling, packaging, warehousing and fulfillment.

For pharmaceutical, biopharmaceutical, medical device and diagnostic manufacturers, the potential value lies in reducing internal infrastructure requirements, preserving manufacturing capacity and consolidating multiple steps of the liquid manufacturing process with one partner.