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Contamination in Pharmaceutical Production

Contamination in Pharmaceutical Production

One of the key responsibilities of pharmaceutical manufacturers is to test the materials used in the manufacturing process to ensure safety and compliance and keep production running smoothly. At SAXOCON, we have the in-house expertise and experience to help you quickly assess and test your production components and materials.

One of the greatest risks manufacturers of pharmaceuticals face is that a product gets contaminated during the manufacturing process. Such an incident can stop production until the contamination source is located and eliminated or, in the worst-case scenario, result in a product recall.

Contamination in pharmaceutical production can occur at every stage of the production process, from sourcing materials to processing the materials to filling the final drug product. Pharmaceutical manufacturers and CDMO facilities can contain thousands of components and materials that can come into contact with the drug products being produced (PCMs).

Good Manufacturing Practice (GMP) provides no guidance on what or how to test PCMs. This is where the BioPhorum Operation Group (BPOG) recommendations and the United States Pharmacopeia – National Formulary (USP) guidelines can help. The BPOG recommendations and USP chapters 665 and 1665 provide guidance about what to test and how to test it. Proper testing and a transparent supply chain with fully identified materials can help reduce the number of unexpected findings and ensure your products are safe, reliable, and compliant.

Check out our services to see how we can help you:
Equipment Safety
Cleaning Validation
Unexpected Findings
Imupurities Testing


BPOG, USP 665 and 1665 and You

BPOG, USP 665 and 1665 and You

In May this year, US Pharmacopeia (USP) chapter 665 will come into effect, and mandatory testing for extractables and leachables (E&L) studies of plastic single-use systems are now required. Moreover, the BioPhorum Operations Group (BPOG) industry collaboration has published protocols that provide comprehensive data, which allows manufacturers to compare materials from multiple suppliers. SAXOCON can help your company ensure that your materials are compliant and that your suppliers provide high-quality, traceable products.

Pharmaceutical manufacturers have increased their use of single-use systems (SUS) to lower costs and increase efficiency. SUS substitutes polymers for glass and stainless steel. Polymers have many advantages but require extra vigilance when selecting materials and vendors.

As polymers present a greater leachables risk, they are subject to greater regulatory scrutiny. These regulations specify the limits that leachables must be under but do not provide guidance about testing.

The USP 665 standard covers the characterisation and qualification of single-use technology (SUT) using plastic components and systems for manufacturing pharmaceutical drug products and biopharmaceutical drug substances and products. One of the central concepts of testing per USP 665 involves exposing materials to temperature extremes and solvents.

USP 1665 provides guidance on applying USP Chapter 665, including suggested risk assessment approaches and how to implement them.

Check out our services here:
Equipment Safety
Impurities Testing
Materials Screening


FDA Recognizes ISO 10993:17

FDA Recognizes ISO 10993:17

The FDA has just recognized the recently updated ISO 10993 Part 17 standard covering the toxicological risk assessment of medical device constituents. Apart from a few exceptions, the FDA recognized the standard for its relevance and scientific and technical merit.

ISO 10993-17:2023 introduces some new concepts for toxicological risk assessments, such as toxicological screening limits (TSLs) and maximum estimated exposure dose (EEDmax), which will improve accuracy and reliability. These significant changes impact medical device manufacturers when preparing to introduce or update products.

As our CTO, Carsten Baun Senholt, is a member of the international technical committee TC 194, which designed the new standard, we are well positioned to offer fully compliant, certified QMS and toxicological risk assessments.

Read more about how we can help you with ISO 10993-17 compliance:

Biological Evaluation Report
Safely Manage Change


Major Change: EU Can Classify Silicone as a Restricted  Substance

Major Change: EU Can Classify Silicone as a Restricted Substance

Do you use silicone in the medical devices you produce? If so, you need to be aware that the European Chemicals Agency (ECHA) can now classify silicone oligomers, specifically D4, D5, and D6 siloxanes, as Persistent Bioaccumulative and Toxic substances (PBT), Very Persistent and Very Bioaccumulative substances (vPvB), and suspected to be toxic to human reproduction after a decisive ruling by the European Court of Justice.

Silicone oligomers are an unavoidable result of the production processes for silicone that must now be accounted for before a medical device containing silicone can be approved for sale in the EU.

At SAXOCON, we have the expertise to properly risk assess the silicone in your products to determine if it meets the new requirements. This ruling marks a change that has far-reaching consequences for new and existing products. Contact us to find out how we can help you determine how compliant your silicone products are.

We have several services to help risk assess your products, including:

Materials screening and selection
Surface characterisation
Device-drug safety


Materials Screening

Materials Screening

Medical device manufacturers need to screen the materials used in their products. Proper biosafety and sourcing require having full transparency about the physical and chemical information associated with the materials throughout the supply chain. Knowing what is in the materials you use helps mitigate risk, reduces unexpected findings, and keeps regulators happy.

To operate in the EU, medical device manufacturers must ensure the quality and safety of the materials used in their products before they can bring them to market. Early and robust materials selection helps meet regulatory requirements, mitigate risk, and get your products to market quickly.

SAXOCON has several services to help you understand your materials and get compliant with all relevant regulations:

Materials Screening
Primary Packaging Safety
Safe Drug-delivery Devices
Surface Characterisation
Safe Food Contact Materials


Nitrosamine Impurities in Primary Packaging

Nitrosamine Impurities in Primary Packaging

Pharmaceutical manufacturers need to know whether their products contain nitrosamine impurities and, if so, whether they are below the thresholds established by various regulatory agencies.

Nitrosamines are highly toxic compounds, with some considered even more carcinogenic than currently established thresholds suggest and are, therefore, subject to strict regulations in both the EU and the US.

The introduction of nitrosamine impurities can occur at any stage of the supply chain, from raw material processing to the manufacturing process to appearing as leachables from packaging and storage.

The EMA and FDA are shifting their focus to packaging materials as a potential source of nitrosamine impurities. This shift in focus means that manufacturers need to know what is in their packaging materials, whether they can leach nitrosamines, and how to mitigate potential problems.

Our services, designed and run by our team of experts, can help you fill in the gaps in your supply chain information and assess your packaging and storage processes for the presence of nitrosamines.

Check out how we can help here.


Updated ISO 10993-17:2023 Standard

Updated ISO 10993-17:2023 Standard

The ISO 10993 standard series covers the biological evaluation of medical devices. Part 17 of this series addresses the toxicological risk of chemical constituents resulting from the chemical characterization of medical devices. In its first major revision in 20 years, the new ISO 10993-17:2023 was published on 13 September. This update has consequences for all medical device manufacturers who must comply with the new requirements.

ISO 10993-17:2023 introduces some new concepts for toxicological risk assessments, such as toxicological screening limits (TSLs) and maximum estimated exposure dose (EEDmax), which will improve accuracy and reliability. These major changes will impact medical device manufacturers when they prepare to introduce or update products.

Our CTO, Carsten Baun Senholt, is a sitting member of the international technical committee TC 194, which designed the new standard. Therefore, our certified QMS and toxicological risk assessments are fully compliant.

Read more about how we can help you with ISO 10993-17 compliance:

Biological Evaluation Report
Safely Manage Change


New FDA NDSRI Guidelines

New FDA NDSRI Guidelines

The Food and Drug Administration (FDA) is updating its guidance regarding Nitrosamine Drug Substance-Related Impurities (NDSRIs). With this update, the FDA acknowledges the leading scientific research by introducing a novel framework for determining the Acceptable Intake (AI) of NDSRIs.

This updated guidance defines five NDSRI potency categories and establishes a framework for setting a scientifically relevant AI based on the compound-specific chemical structures of identified NDSRIs. Most interestingly, the agency recognizes that setting a fixed AI limit for the total level of a mix of different nitrosamine impurities may be impractical if the potency categories of the implicated NDSRIs vary greatly.

This guidance is for immediate implementation, and the agency recommends reevaluating the NDSRI risk in your products before November 2023.

SAXOCON provides toxicological risk assessments of NDSRIs that help your products meet agency expectations.

Check out how we can help here.


New ECHA Chemicals Enforcement Project

New ECHA Chemicals Enforcement Project

The European Chemical Agency (ECHA) is launching a project to check the compliance of products sold online with REACH and CLP requirements. Currently, chemical products sold online are largely non-compliant. Starting in 2025, ECHA inspectors will check products sold online for compliance and, thanks to stricter rules governing online sales, have enhanced enforcement mechanisms.

Are you sure the products you sell online are ready for the upcoming stricter inspections? According to the ECHA, probably not, as they found that 78% of tested mixtures and articles sold online were non-compliant.

We can help you ensure that your products comply with the new regulations, allowing you to continue to sell online without interruption.

Read more about how we can help her.


Particulate Contamination

Particulate Contamination

Particulate contamination is a risk in pharmaceutical production facilities. Good Manufacturing Practice (GMP) and proper risk management requires identifying root causes and evaluating what impact a particulate matter finding has on product safety. Understanding the risk as quickly as possible is crucial when deciding whether to release or recall affected product batches.

SAXOCON has the facilities, expertise, and experience to quickly assess, process, and mitigate any unexpected findings. We can test for particulate contamination according to ISO 8536, “Infusion equipment for medical use part 4: Infusion sets for single use, gravity feed, A.2 Test for particulate contamination”, with the ability to filter up to 20 samples and analyse 20 filters. Once testing is completed, we send a comprehensive report of the results.

Check out how SAXOCON can help here and here.


Nitrosamine Contamination

Nitrosamine Contamination

As a pharmaceutical manufacturer, you need to know whether your products contain nitrosamine impurities and, if so, whether they are below the thresholds established by various regulatory agencies.

Nitrosamine impurities can be introduced at any stage in the supply chain, during manufacturing, or as leachables from packaging and storage.

Nitrosamines are highly toxic compounds, and some are considered even more carcinogenic than currently established thresholds suggest and are subject to strict regulations in both the EU and the US.

At SAXOCON, we have the expertise and services to help you to fill in the gaps in your supply chain information, and test and assess your manufacturing, packaging, and storage processes for the presence of nitrosamines and how they impact your drug substances and products.

Check out how we can help here.


ISO 10993-17 Development

ISO 10993-17 Development

We are very proud that our CTO, Carsten Senholt, has a central role in the international writing group developing ISO 10993-17, which was recently submitted as a final draft.

The ISO 10993 series is a suite of standards covering the biological evaluation of medical devices. The newly revised part 17 now covers the toxicological risk assessment of medical device constituents.

This work started over seven years ago and, compared to the 2002 edition, is a fundamental update on how to conduct toxicological risk assessments of medical devices.

We have already implemented this new approach into our processes via our ISO 13485-certified quality management system.

We can help you keep up with the changing world of medical device guidelines.

Read more about how we can help here.