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Pharma and Life Sciences
Start-to-Finish Confidence for the Pharmaceutical and Life Sciences Industry
Ensuring a safe and sterile product is critical regardless of process stage or end application. Through proper monitoring and treatment from the start, you can ensure your quality standards are met at each stage of the process. Real-time analysis during intake can improve process efficiency and quickly determine changes to be made to the incoming water quality and conditioning, filtration effectiveness and microbiological quality.
Manufacturing processes in the pharmaceutical and the life sciences industries (small molecules, biologics, medicinal products and medical devices) can require a substantial amount of water. Various water types and testing variables (pH, conductivity, TOC, etc.) make water a more complicated component than one might think.
Hach® provides you the tools to generate accurate, consistent parameter measurements without production interruptions.
Process Overview
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Quality Control Laboratory (QA, QC, GMP Labs)
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The incoming water is analyzed to protect the production water preparation unit. |
The incoming water is purified to remove unwanted (dissolved) particles and reduce biohazard. |
The purified water parameters are adjusted to the final use needs. |
The wastewater is treated to conform to the local regulations. |
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Hach Provides Solutions
Our suite of lab and process instrumentation can help you navigate day-to-day routine testing, unforeseen changes and challenges. We can support regulatory compliance needs and help increase safety and effectiveness, while also providing insight to minimize risk and negative impacts.
Hach solutions can help address your pharmaceutical plant’s needs for pure and ultrapure water treatment, steam generation, cooling processes and industrial wastewater management.
Featured Parameters and Solutions
Liquid Color
Why?
Validation of product compliance according to color specification works to ensure pharmaceutical drug production consistency. Color differences in the product can cause customer concern regarding product quality and safety.
Where?
- Final production quality control
- Raw material quality control
Ozone
Why?
Ozone sanitation can be a critical element in efficient disinfection and sanitization of water.
Ozone disinfection is considered to be the primary mechanism for the inactivation/destruction of pathogenic organisms to prevent the spread of waterborne diseases. Due to ozone being a very strong oxidant and virucide, it is typically generated onsite due to its instability and rapid decomposition. 1
1National Small Flows Clearinghouse. “EPA Wastewater Technology Fact Sheet – Ozone Disinfection.” EPA 832-F-99-063; September 1999 https://www3.epa.gov/npdes/pubs/ozon.pdf
Where?
- Pre-production stage
Conductivity
Why?
Conductivity analysis is a key parameter for water pureness measurement.
Various cleaning solutions are more conductive than the water used for flushing, making conductivity measurement a logical way to monitor the cleaning steps and the final rinse. It can also provide certainty there are no impurities in your water (e.g. salt impurity).
Hach conductivity solution fully complies with USP 645.
Where?
- Pre-production water
- Production water
- Wastewater treatment
Hach's Solutions
Please contact your local sales representative or our technical support specialists.
Turbidity
Why?
Turbidity gauges water’s cleanliness by measuring light reflection off of suspended particles – specifically particles such as proteins, minerals, bacteria, algae, dirt and oil. Quality and compliance are just a few reasons to measure turbidity in lab activities and pharmaceutical processing.
Where?
- Pre-production process
- Lab monitoring
Chlorine
Why?
A strong oxidizing agent, chlorine (Cl2), is an ideal disinfectant. When used for disinfection, free chlorine forms when chlorine gas is dissolved in water.
Too much chlorine in water can have detrimental effects in pharmaceutical production, membrane treatment processes and other applications. For example, chlorine can damage active pharmaceutical ingredients (API) during production, resulting in poor product quality or product loss. It can also have detrimental effects on other process instrumentation that could be costly to repair and decrease system lifetimes. In addition, chlorine has to be monitored constantly to follow the Clean-In-Place (CIP) procedure.
Where?
- Piping and vessels used in pharmaceutical production
TOC
Why?
High TOC concentrations in water can significantly impact ecosystems and damage manufacturing equipment when left unchecked and untreated.
Organic compounds can be liquid, dissolved in water or exist in water as undissolved, suspended material. This organic matter can enter water naturally and through man-made sources/processes.
Organic compounds are precursors for disinfection byproducts (DBP), which are strictly regulated in the water industry.
Measuring TOC makes it possible to implement the right treatment to reduce the formation of DBP to comply with the regulatory requirements.
Where?
- Pre-production in pharmaceutical manufacturing
- Production stage water quality confirmation
- Post-production wastewater treatment and lab water measurement
Lab Instrumentation
Why?
Innovation comes from laboratories. Hach provides a full-service line of high-quality instrumentation and equipment to help deliver innovation and accuracy in your laboratory experiments.
Where?
- Drug development stage
- Pre large-scale production
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