Clear Solutions Laboratories-Blog

PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2025

CSL — Wed, 22 Oct 2025 14:00:00 GMT

We are excited to be co-presenting with Brevetti-CEA Spa at the PDA - Universe of Pre-Filled Syringes and Injection Devices in Vienna:

“AI-Driven Automated Visual Inspection for Combination Products: Challenges and Solutions in Large-Scale such as GLP-1 Manufacturing”

The PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2025 is a leading industry event focused on advancing the drug delivery ecosystem for injectable combination products. Bringing together pharmaceutical companies, technology providers, healthcare professionals, and innovators, the conference explores how science, digital technologies, patient experience, and sustainability are shaping the future of drug delivery.

Through keynote presentations, expert talks, and interactive sessions, attendees will gain insights into emerging trends such as advanced injection systems, digital health integration, AI-driven testing, and sustainable device design. Real-world case studies and discussions will address challenges in usability, device performance, and combination product development.

The event also features an exhibition showcasing the latest injection device technologies, startup innovation pitches, and networking opportunities with industry leaders. Overall, the conference provides a platform for knowledge exchange, collaboration, and innovation to improve patient-centric drug delivery solutions.

Link to conference: https://pda.org/global-event-calendar/event-detail/pda-universe-of-pre-filled-syringes-and-injection-devices-conference-2025-archived

Impact of color on detectability of fibers in visual inspection

Andreas Zerr — Fri, 10 Oct 2025 12:30:00 GMT

Authors

Filip M. Fedorowicz, Andreas Zerr, Roman Mathaes, Matthias Eisele, Swen Maas, Atanas Koulov

Abstract

Visual inspection in pharmaceutical manufacturing and quality control ensures that products are “practically/essentially free” of visible particles. The process relies on solid training and robust qualification programs for operators. Visual inspection is probabilistic, hence it is highly important to understand well the factors that define detectability of particles. Examples of such important factors are particle size, particle behaviour, primary packaging characteristics and properties of the product. This study aimed to assess the impact of one such factor - color - on the detectability threshold of fibrillar particles. Three types of colored fibers - two achromatic (black and white) and one chromatic (red), were used in a threshold study under compendial visual inspection conditions. The surprising and unexpected findings of the study demonstrate that contrary to conventional wisdom, fiber color does not appear to impact detectability.

Read the full publication: https://www.sciencedirect.com/science/article/pii/S0022354925004162

Challenges for Visual Inspection and Particle Control in Cell Therapy Products

Roman Mathaes — Mon, 06 Oct 2025 02:15:00 GMT

Authors

Roman Mathaes, Antonio Burazer, Satish K. Singh, John G. Shabushnig and Atanas Koulov

Abstract

Cell therapy products represent a transformative class of advanced medicinal products with unique manufacturing and quality control challenges. Unlike conventional parenteral products, cell therapies consist of living cells—typically delivered as turbid, non-filterable suspensions—which inherently complicates the control and detection of visible (VP) and subvisible particles (SvP). This review outlines the distinctive risks associated with particle generation in autologous and allogeneic cell therapies and highlights limitations of existing pharmacopeial methods for particle testing.

We identify three major sources of particles in cell therapy products: the manufacturing process with often several manual manipulation steps, the single use manufacturing components, and the container closure systems. The complexity of the process is compounded by small batch sizes, short shelf-life, and complex formulations, and thus traditional sampling and visual inspection approaches have limitations in their utility. Therefore, cell therapy products often require tailored inspection strategies and supplemental process simulations.

We review the current global regulatory requirements (USP <790>, Ph. Eur. 2.9.20, JP 6.06), contrast US and EU definitions for particle types, and discusses practical gaps in harmonization. We further evaluate emerging technologies like flow imaging microscopy for SvP characterization and propose optimized visual inspection strategies tailored for turbid cell suspensions. However, preventative or preemptive control, rather than end-stage inspection, is recommended as the most effective strategy. This requires systematic risk assessment, raw material control, process simulations, and supplier collaboration.

The authors advocate for the development of cell therapy-specific inspection standards and call for regulatory alignment to support consistent global development and patient access.

Read the full publication: https://journal.pda.org/content/early/2025/10/16/pdajpst.2025-000021.1

ISO 9001:2015 - Quality management systems

CSL — Sun, 20 Jul 2025 07:00:00 GMT

Clear Solutions Laboratories is ISO 9001 certified. This milestone reflects our ongoing commitment to quality, continuous improvement, and exceeding our customers’ expectations.

Clear Solutions Laboratories is proud to be ISO 9001 certified, an internationally recognized standard for quality management systems. ISO 9001 certification confirms that our processes, procedures, and management practices meet rigorous requirements designed to ensure consistent quality, reliability, and continuous improvement.

Achieving this certification demonstrates our commitment to maintaining high operational standards while delivering reliable and high-quality services to our customers and partners. The ISO 9001 framework helps organizations improve efficiency, strengthen process control, and enhance customer satisfaction through structured quality management and ongoing performance evaluation.

For Clear Solutions Laboratories, this milestone reflects our dedication to excellence, transparency, and continuous development. By aligning our operations with internationally recognized quality standards, we ensure that our services consistently meet both regulatory expectations and the needs of our clients.

PDA Visual Inspection Forum 2026

CSL — Tue, 20 May 2025 03:30:00 GMT

We are excited to be part of the PDA Visual Inspection Forum 2026 and present:

“Risk-Based Design of VI Qualification Test Sets: Data-Driven Justifications for Bracketing Approaches.”

The PDA Visual Inspection Forum 2026 is a key industry event dedicated to advancing visual inspection practices to ensure the safety and quality of sterile and parenteral products. Bringing together professionals from industry, academia, and regulatory authorities, the forum focuses on the latest developments in particle control, inspection technologies, and regulatory expectations across the entire product lifecycle—from early development to commercial manufacturing.

Through keynote presentations, expert sessions, and real-world case studies, participants will explore current challenges and innovations in visual inspection, including automated and intelligent inspection systems, data-driven qualification strategies, and modern training approaches. The program reflects the growing shift toward digitalization, harmonization, and smarter inspection solutions within pharmaceutical manufacturing.

The event also offers interactive poster sessions, roundtable discussions, and an exhibition showcasing the latest technologies in visual inspection. Overall, the forum provides a collaborative platform for knowledge exchange, networking, and shaping the future of inspection science to better safeguard sterile drug products.

Link to conference: https://www.pda.org/global-event-calendar/event-detail/pda-visual-inspection forum-2026#related-events

CASSS - WCBP 2026

CSL — Wed, 29 Jan 2025 01:15:00 GMT

We are pleased to contribute with two presentations at CASSS WCBP 2026:
“Visible Particle Control in Biologics and Advanced Therapy Products” & “Tackling the Polysorbate Degradation Challenge”

The WCBP Symposium series has established a reputation as the most highly-regarded annual conference addressing the role of current and emerging CMC analytical technology among evolving US and international regulatory perspectives.

Biopharmaceutical manufacturers and academics along with regulatory agency representatives have used the WCBP Symposium to describe and discuss successful approaches in plenary sessions and informal workshop discussions. The interactive format of the Symposium has proven to be an effective means of benchmarking strategies and clarifying expectations among the regulatory and technical experts.

Hear from and engage with thought leaders on a wide range of topics including device/combination products challenges, microbiological considerations, breakthrough technologies for comparability and characterization, immunogenicity, and sustainability.

Link to conference: https://www.casss.org/meetings-and-events/multi-day-symposia/wcbp

Definition of Particle Visibility Threshold in Parenteral Drug Products—Towards Standardization of Visual Inspection Operator Qualification

CSL — Mon, 13 Jan 2025 01:15:00 GMT

Authors

Filip M. Fedorowicz, Andreas Zerr, Roman Mathaes, Matthias Eisele, Swen Maas and Atanas Koulov

Abstract

The detectability size threshold of visible particles (“visibility” size) in the context of visual inspection of parenteral drug products has been an elusive target for several decades. The current common sense, also reflected in official guidelines, dictates that particles of different shapes and morphologies have different “visibility” size thresholds, which can range between hundreds and thousands of micrometers. This study demonstrates experimentally for the first time that it is possible to define a single, shape- and morphology-independent detectability size threshold, identical across particles of various types, provided that observation conditions and product attributes are kept constant. We propose that, based on the physiology of human visual perception instead of single-dimension measures of particle size (e.g., diameter or length), such a single size-threshold requires the use of area-based size parameters (such as “equivalent circular diameter”, or ECD. The experimental results reported here clearly demonstrate that the “visibility” thresholds for particles of various morphologies converge on a single ECD value. In addition, the data reported here show that product attributes, such as container configuration, fill volume, etc. influence the threshold of visibility. Collectively, the findings reported in this paper provide substantial evidence and scientific rationale, as well as unanticipated prospects for standardization of visual inspection qualification practices, ultimately leading to improvement of pharmaceutical product quality.

Read the full publication: https://journal.pda.org/content/79/1/28