BRINGING BIOPROCESSING TO LIFE
At Parker, we use the latest technologies and our longstanding engineering expertise to bring bioprocessing to life. By utilizing the latest innovations and technical advances in biopharma engineering we create processing solutions that make a positive difference both to the industry and people’s lives.
Oil and Gas Trend Highlights
Application of Pre-Use Post Sterilization Integrity Testing
Considerations for implemenation
The latest revision of EU GMP Annex 1: Manufacture of Sterile Medicinal Products (August 2023) included PUPSIT as a default requirement for manufacturers using filtration to sterilize their final product. This white paper discusses the considerations and challenges for the incorporation of PUPSIT into both single-use and hard piped processes including filter selection and integrity test method, and system design, location and operation.
Improving Final Fill Processes and Addressing Annex 1 Requirements
with PureTain® Single-Use Technology
This white paper explores the evolving role of single-use systems in addressing the critical challenges in final fill processes, particularly in meeting stringent regulatory requirements. Learn how Parker´s PureTain® solutions are reshaping processes, enhancing efficiency, and ensuring sterility, while aligning with regulatory standards.
Parker`s Solutions for Final Fill Processes
Featured Products
SciLog FD Automated Bulk Filtration and Dispense System
Single-Use Isolator Transfer Set, PureTain®
PureTain® Final Fill Manifolds
PROPOR SG Sterilizing Grade Pharmaceutical Filters
SciPres Single Use Biopharmaceutical Pressure Sensors
Browse our Bioprocessing Technologies
Single-Use Solutions
Parker utilizes the latest technologies and extensive engineering and process expertise to advance bioprocessing with our PureTain® single-use solutions.
Bioprocess Automation
The use of automation in running complex single use processes has many benefits including improving process control and consistency, increasing speed, and reducing human error deviations.
Filtration
From clarification and bioburden reduction to sterile filtration and Mycoplasma removal, Parker offers a range of liquid and gas filters for all your filtration requirements. Filters can be incorporated into our SciLog® single-use systems to enhance process control and increase productivity.
Single-Use Sensing
Parker’s single-use sensors for pressure, temperature and conductivity measurement enhance bioprocess control and safety making them fundamental for monitoring critical applications such as virus filtration, ultrafiltration and diafiltration and bulk drug dispense.
More Bioprocessing Applications
Cell Culture
Harvesting
Buffer Preparation
Purification & Concentration
Bulk Fill
Freezing
PUPSIT
ATMP
Related Content
How SciLog® Bulk Dispensing & Filtration Eliminates Inefficiency
Article
Read how automating, standardizing and enclosing bulk biopharmaceutical filtration and dispense in a single unit operation can drive bioprocess efficiency.
How to Mitigate the Contamination Risk in Biopharma Production
Blog Post
Learn how to mitigate contamination risks in biopharma final fill processes by implementing Parker´s PureTain® single-use solutions and overmolding technology.
The Cost of Failing to Protect Your Final Biopharmaceutical Product
Blog post
Sometimes, simple errors or avoidable mistakes and damage can have huge ramifications if a high-value final product is lost. Read how to best protect your product:
Single-Use Systems for Final Fill Applications
Case Study
Discover how we helped one pharma giant design a more reliable, cost-effective filling line with our PureTain Single-Use System.
Comprehensive Biopharmaceutical Solutions
Parker Bioscience Filtration combines filtration, bioprocess containers, single use assemblies and sensing technology to create scalable and automated system solutions for a wide range of biopharmaceutical applications.
Bioprocessing and Medical Technologies
Product Catalogue
Parker designs breakthrough bioprocessing technologies to aid our life sciences industry partners in developing and manufacturing pharmaceutical products and also supports patient care by supplying essential components used in medical equipment.
PureTain® Single-Use Solutions for Bioprocessing
Bioprocess Containers, Single Use Assemblies, Single Use Tubing, Aseptic Sampling Systems
Parker offers customer-specific single-use assemblies and systems for biopharmaceutical lab-scale to commercial GMP-scale applications.
Upcoming Events
October, 02, 2024, Foxboro (MA), USA
October 13-16, 2024, Orlando (FL), USA
December 3-4, 2024, Heidelberg, Germany
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About Parker Final Fill Solutions
Discover Parker’s latest technical advances and innovations in biopharma processing, designed to support the most complex final fill processes, including Parker PureTain® single use assemblies, single use tubing and aseptic sampling systems.
Benefit from fast, economical and validated sterile filtration of pharmaceutical liquids with Parker’s High Capacity PROPR HC and Sterilizing Grade PROPOR SG liquid filters. Up to 3.5 times higher flow rates than other sterilizing grade filters, with low binding for minimal product loss.
PureTain® single use final fill manifolds ensure an aseptic product transfer and filling process from the bulk tank to the needle, delivering maximum levels of integrity and accuracy to guarantee a contamination-free and precisely dosed single product.
Parker PureTain® Isolator Transfer Sets – single use systems for final filling applications – deliver smooth transitions between tubing and connectors, with a unique port design for beta bags and canisters, for seamless tubing transfer of filling lines into the isolator.
And Parker’s overmolding solutions ensure maximum protection against contamination through validated and completely closed systems, with smooth flow and fully controlled fluid path dynamics.
Find out more about Parker’s SciLog FD® System, an automated single use system for the final bulk filtration and dispense of biopharmaceutical products into bags or bottles. Designed to minimize product losses and maximize yield, the system supports compliance and regulatory requirements with a full validation package, securely retaining audit trail and batch record data.
The latest revision of the EU GMP Annex 1 makes Pre-Use Post Sterilization Integrity Testing (PUPSIT) a default requirement for biopharmaceutical processing, and Parker’s innovative final fill solutions meet and exceed regulatory requirements for both single use and hard piped processes. Parker’s advanced PureTain® products deliver problem-solving solutions to the critical challenges in modern final fill processes. Read how in our white papers “Improving Final Fill Processes and Addressing Annex 1 Requirements” and “Application of Pre-Use Post Sterilization Integrity Testing”.