More substances can dissolve in water than any other chemical.
Water – The Key to Life and Manufacturing
The Types of Water
It’s known that water is a key component for sustaining life. Our bodies are on average 60% water, but have you ever thought about the different types of water out there? No, we aren’t talking about sparkling and flavored water, but the different grades of water! Below we’ll look at some of the common types of water we encounter in our lives!
The Properties of Water
H-2-O, we all know that water is literally all around us, but it has some important properties to keep in mind as we go through this FSF issue.
Universal Solvent
Sustaining Life
Water’s properties make it an ideal environment for life to grow.
Neutral pH
Water has a neutral pH of 7.0. It’s neither very basic, nor very acidic.
The States of Water
Solid, Liquid, Gas – we know the states of matter, but let’s look closer at the states of Water:
Solid
Water crystallizes below its freezing point into a solid structure – ice! Ice is generally crystalline lattice.
Liquid
Liquid water – we all know it. It can take the shape of any container, great for cooking and cleaning, and has a host of uses!
Gas
Once liquid water boils, it turns into a vapor at which it is in the air around us. This is the reason humidity exists – the amount of water vapor in the air!
Fresh/Potable Water
Fresh/Potable (drinkable) water is the most common water we interact with in our lives. It comes from natural sources and is treated for bacteria, toxins, etc. before we drink it.
Bacteria: Not sterile
Minerals: Present
Purity: Standard
Deionized Water
Deionized water is water treated to remove ions and minerals, such as calcium and chlorine, via ion-exchange.
Bacteria: Not sterile
Minerals: Removed
Purity: High
Purified Water
Purified water is produced via ion exchange, reverse osmosis, and distillation processes. This removes all minerals and non-water components and most organisms. This is highly pure water.
Bacteria: Mostly sterile
Minerals: Removed
Purity: Higher
Water For Injection (WFI)
Water For Injection is one of the highest grades of water available. It has been treated extensively to remove all ions, organisms, non-water components, and most pyrogens like endotoxins.
Bacteria: Sterile
Minerals: Removed
Purity: Highest
Water in AbbVie Manufacturing
So, now we know some more about the different grades of water, but how does it pertain to what we do at AbbVie? Well, just like how water is a key component to life, it’s also a key component in our manufacturing processes. From making the API to the final drug product, water plays an integral role. Check out some of the ways we use water at AbbVie!
Drug Substance
Within our Drug Substance manufacturing processes, water is often used because many compounds can dissolve in it – like we mentioned it’s a universal solvent. An important aspect to reaction chemistry is being able to dissolve reactants before a reaction.
Most drug substance processes will use Purified or Deionized water as there are less components in the water that could interfere with any reactions.
Fermentation
We have many products that require Fermentation to develop the bulk drug substance. Since fermentation is a process in which cells are intentionally grown, it’s imperative the fermenter is free of contaminating organisms. As such, WFI is often used, if not, a water source that is sterilized prior to use... more on that below!
Aseptic Filling
Many final drug products that come in vials require WFI to be used. This is because these products are often injected directly into a patient’s bloodstream where sterility is a must for patient safety.
Since WFI is free of microorganisms and bacteria, it ensures patient safety, however, the filling lines also must be fully sterile. That is where media fills come into play – to ensure the sterility of the manufacturing process!
Cleaning & Sterilization
As you experience in your household, water is extremely effective at cleaning manufacturing equipment. This is tied to its role as a universal solvent! The type of water required is process dependent and established through cleaning validations.
Water itself can be used as a sterilizing agent. Steam is extremely hot and can kill many microorganisms; this is often used to sterilize fermentation equipment. Additionally, steam can be used to sterilize some process streams!
