4.3 Cooperation with third countries (2023)

Cases involving third countries

Eurojust's international cooperation continues to result in an increasing number of cases registered with the Agency, with 331 new third-country property cases initiated in 2022 alone. In 2022, Eurojust was requested to be involved in cases involving countries with a liaison prosecutor 569 times. In addition, 35 cases concerned countries that had a cooperation agreement with Eurojust but had not yet appointed a Liaison Prosecutor at the Agency. Countries with designated Eurojust contact points were asked to participate in 79 cases. The UK is the third country with the most cases (315 cases in 2022), followed by Switzerland, Norway, Albania, Serbia and Ukraine.

Case review in 2022 with Liaison Prosecutors

Liaison prosecutorCases initiated by the Liaison ProsecutorParticipation in cases initiated by other OfficesParticipation in joint activities/meetings
New in 2022Number of countries involvedContinuous from previous yearsNew in 2021Continuous from previous yearsMeeting coordinatesJITdays of action
23 or more
north macedonia431112140801
United Kingdom474165426871279294

*These columns cannot be summarized as more than one National Office may be called upon for a single case and coordination meetings and JITs are often organized jointly.

Suppression of a money laundering and fraud criminal network

4.3 Cooperation with third countries (1)

September 2019 -The suspects allegedly set up companies in Romania and opened bank accounts for them, from which consistent and successive transfers (estimated at over €70 million) are made in fraudulent activities. A case is opened in an organized crime group suspected of money laundering and fraud at Eurojust.

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June 2020 -A JIT has been set up between Romania and Ukraine, which will be extended to Italy in June 2021. Eurojust supports judicial cooperation and coordination in more than 20 countries, organizes 4 coordination meetings and facilitates the execution of many EIO and MLA requests.

December 6, 2020 -In one day, nine suspects were arrested in Romania and one was put under judicial supervision. A total of 24 house searches are carried out, 13 in Romania, 7 in the Republic of Moldova and 4 in Sweden. The total value of seized assets exceeds EUR 5 million.

4.3 Cooperation with third countries (2)

International agreements with third countries

In March 2021, the Council adopted a decision authorizing the European Commission to open negotiations on international cooperation agreements with Eurojust between 13 third countries[1]and the European Union. Negotiations with Armenia are advanced. As noted in the Commission's reportFifth Progress Report on the implementation of the EU's Security Union Strategypublished in December 2022, official negotiations have also started with Colombia, Algeria and Lebanon. In 2022, Eurojust was in close contact with the Commission services and attended negotiation meetings as an observer.

Liaison prosecutors

Hosting Liaison Prosecutors from non-EU countries at Eurojust's premises in The Hague allows Member States' authorities to work closely with their judicial authorities. This allows direct involvement in operational cooperation between them, leading to more effective investigations and prosecutions.

Currently, 10 third countries have liaison prosecutors at Eurojust: Albania, Georgia, Montenegro, North Macedonia, Norway, Serbia, Switzerland, Ukraine, the United States and the United Kingdom. The UK has had a Liaison Prosecutor with the Agency since 2021 under the EU-UK Trade and Cooperation Agreement, andworking layoutsigned with Eurojust in the same year.

Employment contracts with external partners

In August 2022, Eurojust signed a working arrangement with the Ibero-American Association of Prosecutors. The purpose of the employment contract is to promote and develop cooperation between the parties in the fight against serious crime affecting the European Union and Latin America, in particular international organized crime, drug trafficking, human trafficking, cybercrime and terrorism.

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Eurojust contact points

Since the beginning of its activity in 2002, the Agency has been expanding its network of Contact Points in third countries, enabling direct contact with the competent authorities of these countries when the crime extends beyond the borders of the EU. To date, the network has Contact Points in over 65 countries.

In 2022, the network of Eurojust contact points was extended to include three new third countries: Australia, Bahrain and Morocco. During the year, the Agency started to organize regular meetings with the contact points to better explain the Agency's role in facilitating judicial cooperation with EU Member States.

4.3 Cooperation with third countries (3)

The operation supported by Eurojust led to the arrest of 29 human traffickers in Italy, Greece and Albania

4.3 Cooperation with third countries (4)

Criminality:A human trafficking network illegally transfers at least 1,100 migrants to the European Union. The suspects make illicit profits of at least several hundred million euros.

Action:In January 2021, a JIT is established with the participation of judicial authorities from Italy, Greece and Albania. In preparation for the day of action, authorities conduct a long-term surveillance of suspects, using telephone and Internet capture of evidence and video recordings. This allows them to document the routes used by the network and identify the perpetrators.

Result:On the day of the operation, supported by Eurojust, Europol and Frontex, 29 suspects of Albanian, Turkish, Syrian, Iranian, Iraqi and Pakistani origin were arrested in Italy, Greece and Albania. Eight of them are arrested during the ongoing smuggling operation and the migrants involved are secured.

The role of Eurojust:In addition to supporting JITs, Eurojust sets up a day-of-action coordination center and provides cross-border judicial support through the Agency's Italian and Greek national offices and the Albanian Liaison Prosecutor.

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4.3 Cooperation with third countries (5)

Collaborate with regions around the world through projects.

Southern Partner Countries (SPC)

Eurojust's growing role and involvement in the SPC continued in 2022 with further implementationEuroMed Justice Program(2020-2023). Eurojust supported the development of practical tools to facilitate cross-border judicial cooperation, developed by the EuroMed Justice Expert Group to provide up-to-date information and tools to criminal justice professionals. In 2022, an updated versionEuroMed Digital Research Handbookwas published. The guide explains the conditions necessary to identify and overcome practical and legal obstacles to e-evidence.

In October 2022, the Secretariat of the European Judicial Network became a member of EMJNet, a network of Contact Points for criminal justice authorities from the SPC and EU Member States. In 2022, Eurojust and the Secretariat of the European Judicial Network (EJN) contributed to the work of the EMJNet and provided guidance on the implementation of the trans-Mediterranean strategies for 2022-2025.

In October 2022IV EuroMed Forum of Prosecutors Generalbrought together high-level prosecution officials from all SPCs and EU Member States at Eurojust. The Forum assessed progress so far and discussed the next steps in implementing the 2022-2025 strategy, including action plans on migrant smuggling, confiscation of proceeds of crime and asset recovery. As part of the event, seven high-level meetings were held with SPC delegations (including representatives of the European Commission) to discuss international agreements between the European Union and the SPC for Eurojust.

Several conferences were organized in 2022 bringing together criminal justice specialists and experts from the SPC and EU Member States. In May 2022, in Athens, in cooperation with the Hellenic Ministry of Justice, a conference was organized to exchange operational experiences and best practices in preventing, investigating and prosecuting migrant smuggling crimes. In the same month, in Lyon, in close cooperation with the French Ministry of Justice, a conference was organized to help judicial and police authorities apply data protection standards when collecting cross-border electronic evidence in criminal matters. In Tunisia, in June 2022, the firstMediterranean ConferenceIn 2016, an environmental justice conference was held where Algeria, France and Tunisia shared good practice on how to best apply environmental law. The conference concerned the development of a network of judges specializing in environmental law on both sides of the Mediterranean.

In addition, the National Judicial Institute in Bucharest and the Belgian Judicial Training Institute co-sponsoredtwo round tablesshare practices in the development of trans-Mediterranean curricula for international judicial cooperation in criminal matters.

Criminal Justice Project in the Western Balkans[2]

In September 2022, Eurojust started work on the so-calledWBCJ project, financed from the EU Instrument for Pre-Accession Assistance. The main objective of the project is to strengthen cooperation within the Western Balkans[3]and between the region and the European Union on the fight against organized crime and terrorism using modern tools and instruments. This will lead to a higher level of interaction and integration between the European Union and the Western Balkans region in the field of criminal justice.

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The Western Balkans region has long been an important ally of Eurojust in the fight against cross-border organized crime. By organizing this project, we are doubling existing efforts and helping to overcome remaining obstacles to judicial cooperation between Western Balkan partners and between them and EU Member States. Our goal is to build long-term, structural partnerships that translate into even better operational results.

Between October and December 2022, the President and Vice-Presidents of Eurojust visited sixpartners from the Western BalkansPresent the project to the participating authorities. The Western Balkans partners have appointed their contact group members who will be responsible for identifying typical cases where coordination would be beneficial. These selected cases will receive financial support and expert advice from Eurojust to facilitate coordinated parallel criminal investigations and prosecutions and JITs.

4.3 Cooperation with third countries (6)

Collaboration with Latin America

WithinPROJECT PACTIn support of closer dialogue with Latin America, Eurojust has developed a guide on cooperation with Eurojust contact points in the region. The guide was distributed to all contact points in July 2022 in Spanish and English. Meetings between Eurojust representatives and Latin American contact points are planned to discuss the implementation of the guide.

Eurojust attended the EL PAcCTO event in Buenos Aires in November 2022 to discuss cooperation between the Agency and the Latin American Focal Points and to share the latest updates on Eurojust's support to JITs.

[1]Algeria, Argentina, Armenia, Bosnia and Herzegovina, Brazil, Colombia, Egypt, Israel, Jordan, Lebanon, Morocco, Tunisia and Turkey

[2]This project is also known as WB CRIM JUST.

[3]Including Albania, Bosnia and Herzegovina, Kosovo*, North Macedonia, Montenegro and Serbia.
*This designation is without prejudice to status positions and is in line with UN Security Council and ICJ Opinion No. 1244 on the Kosovo Declaration of Independence.


What are the requirements for GMP in the EU? ›

GMP requires that medicines: are of consistent high quality; are appropriate for their intended use; meet the requirements of the marketing authorisation or clinical trial authorisation.

What happens when a member country does not agree with a decision made by the EU government? ›

If no agreement can be reached, the proposal is withdrawn. The EU treaties specify who can pass laws in what areas: the EU, national governments or both. EU countries are responsible for making their own decisions and laws in certain areas of national policy like industry, health and education.

What is the EU GMP guideline Annex 1? ›

Annex 1 of EU GMP provides specific guidance on the manufacture of sterile medicinal product. The new version of Annex 1 has been expanded considerably and now contains a strong focus on risk management and having a contamination control strategy.

What is one of the major reasons why these European countries decided to join together to form the European Union? ›

The modern European Union, founded in 1992, has its origins in post–World War II attempts to integrate European economies and prevent future conflicts. It consists of seven major institutions and dozens of smaller bodies that make law, coordinate foreign affairs and trade, and manage a common budget.

What are the 5 principles of GMP? ›

Good manufacturing practices (GMPs) help to ensure the consistent quality and safety of products by focusing attention on five key elements, which are often referred to as the 5 P's of GMP—people, premises, processes, products and procedures (or paperwork).

What are GMP regulatory requirements? ›

GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.

What countries refuse to join the EU? ›

Of the four major western European countries that are not EU members, Norway, Switzerland and Iceland have submitted membership applications in the past but subsequently frozen or withdrawn them, while the United Kingdom is a former member.

Do all members of the EU have to agree? ›

Membership negotiations cannot start until all EU governments agree, in the form of a unanimous decision by the EU Council, on a framework or mandate for negotiations with the candidate country.

Can a member state be kicked out of the EU? ›

Expulsion. While a state can be suspended, there is no provision to expel a member state outright. The idea appeared in the drafting of the European Constitution and the Lisbon Treaty but failed to be included. There are a number of considerations which make such a provision impractical.

What are Annex 1 limits? ›

EU GMP Annex 1 specifies limits of air-borne particles concentration for particle sizes > 0.5 µm and > 5.0 µm. The US FDA requests control of those for 0.5 µm only.

What is EU Guidelines Annex 11? ›

Annex 11 was created to ensure that when a computer is used in place of a manual operation in the manufacture of pharmaceuticals, there is no further risk to limb or paw when it comes to product quality, efficacy, or patent safety. While Annex 11 is not a legal requirement, it is a strongly recommended guideline..

What is the difference between 21 CFR Part 11 and EU Annex 11? ›

While the FDA 21 CFR covers US-based pharmaceutical companies, Annex 11 is a Good Manufacturing Practice (GMP) guideline in the European Union. 21 CFR part 11 is a regulation of the FDA that applies to drug manufacturers, biotech companies and other regulated industries.

Why isn't Norway in the EU? ›

Norway had considered joining both the EEC and the European Union, but opted to decline following referendums in 1972 and 1994. According to the European Social Survey conducted in 2018, 73.6% of Norwegians would vote 'No' in a Referendum to join the European Union.

What countries are waiting to join the EU? ›

The EU has a strict set of criteria that candidates must meet in order to be accepted, and the process can take many years. The list of candidate countries currently includes Albania (2009), Montenegro (2008), North Macedonia (2004), Serbia (2009), Turkey (1987), Moldova (2022), and Turkey (2022).

Can Ukraine join EU? ›

Average EU member

On 23 June 2022, the European Parliament adopted a resolution calling for the immediate granting of candidate status for EU membership to Ukraine. On the same day, the European Council granted Ukraine the status of a candidate for accession to the EU.

What are the 4 elements of GMP? ›

Sample of the products needs to make sure that: (i) system is working; (ii) products meet specification; (iii) products will be effective for their intended use; and (iv) Products are safe.

What does 5S mean in GMP? ›

Methods: The 5S methodology consists of the following steps: Sort, Set in Order, Shine, Standardize, and Sustain. A “red tag” exercise was conducted to identify critical versus unnecessary items in the work area.

What are 4 m of GMP? ›

The mainstay of GMP is the 4M principle; Men, machines, material and manufacturing premises. All these 4Ms are equally important.

What is an example of GMP? ›

Examples of good manufacturing practices that help ensure product safety and quality include: Incoming raw materials are inspected for quality. An allergen control program is in place. Product recalls are well-documented and controlled.

Why C is small in cGMP? ›

cGMP is a unique term to define most recent guidelines with improvement and additions. c is a variable in cGMP that's why it is written in small letter just like pH → p is variable potential in pH.

Why is Switzerland not in NATO? ›

According to Swiss president Ignazio Cassis in 2022 during a World Economic Forum speech, the laws of neutrality for Switzerland are based on The Hague agreement principles which include “no participation in wars; international cooperation but no membership in any military alliance; no provision of troops or weapons to ...

Why is Switzerland not in EU? ›

Chronology of the Swiss votes

6 December 1992: joining the European Economic Area is rejected by 50.3% of voters. This vote strongly highlighted the cultural divide between the German- and the French-speaking cantons, the Röstigraben.

Why didn t Russia join the EU? ›

Russia has chosen not to participate in the EU's European Neighbourhood Policy (ENP), as it aspires to be an "equal partner" of the EU (as opposed to the "junior partnership" that Russia sees in the ENP). Consequently, Russia and the EU agreed in 2005 to create four Common Spaces for cooperation in different spheres.

Why is Turkey not in the EU? ›

Since 2016, accession negotiations have stalled. The EU has accused and criticized Turkey for human rights violations and deficits in rule of law.

Why did the EU reject Ukraine? ›

According to observers, this is due to such factors as the unwillingness of the EU to expand to the post-Soviet space, the poor performance of the Ukrainian economy, the lack of democracy (during the 1990s), and the internal instability (following the Orange Revolution).

Which states are not members of the EU? ›

European Countries (NON-EU)
  • Albania. See Entry Requirements for Albania. ...
  • Azerbaijan. See Entry Requirements for Azerbaijan. ...
  • Georgia. See Entry Requirements for Georgia. ...
  • Liechtenstein. See Entry Requirements for Liechtenstein. ...
  • Montenegro. See Entry Requirements for Montenegro. ...
  • Serbia. See entry requirements for Serbia. ...
  • Turkey.

Could Hungary leave the EU? ›

Hungary is legally allowed to leave the EU according to Article 50 of the Treaty on European Union.

What happens if an EU Member State is attacked? ›

This clause provides that if a Member State is the victim of armed aggression on its territory, the other Member States have an obligation to aid and assist it by all the means in their power, in accordance with Article 51 of the Charter of the United Nations.

Do you have to be a democracy to be in the EU? ›

How do countries join the EU? Any European country that agrees to promote the EU's common values – respect for human dignity and human rights, freedom, democracy, equality and the rule of law – and meets certain conditions, referred to as the “Copenhagen criteria,” is eligible to apply for membership.

What is the difference between Annex I and non-Annex I? ›

Annex I parties are industrialized nations and are legally bound to reduce greenhouse gas emissions once they have ratified the agreement. In contrast, Non-Annex I parties (developing nations) are only required to report emissions.

What is the difference between Annex I and Annex B? ›

Annex I refers to the 36 countries identified for reduction in the UNFCCC while the Annex B is an adjusted list of 39 countries identified under the more recent Kyoto Protocol. Annex B countries have their reduction targets formally stated.

Is China Annex 1? ›

China is a party to the United Nations Framework Convention on Climate Change (UNFCCC), and has ratified the Paris Agreement. It belongs to the non-Annex I groupof developing countries, which have less strict requirements and are entitled to support from the developed countries listed in Annex I of the convention.

What is EudraLex Annex 15? ›

This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.

What is GAMP 5 guidelines? ›

GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advances.

Is Annex 11 a law? ›

Though Annex 11 is not a legal requirement, following its guidance is essential to compliance with related EU regulations. Aligning with Annex 11 can help make certain that the use of computers in the pharmaceuticals manufacturing process does not elevate quality, product and efficacy risks.

How are Annex 11 and Part 11 different? ›

Part 11 is mainly about using electronic records and signatures in computer systems, while Annex 11 focuses on quality management of computerized systems. Part 11 requires electronic records and signatures to be trustworthy and reliable like paper records and handwritten signatures.

Who must comply with 21 CFR Part 11? ›

21 CFR Part 11 applies to clinical trial sponsors, including pharmaceutical and medical device companies, who are conducting FDA-regulated research. It also applies to Clinical Research Organizations (CROs) and research sites.

What is the FDA equivalent in Europe? ›

European Food Safety Authority (EFSA) : EFSA is an agency of the European Union set up in 2002 to serve as an impartial source of scientific advice to risk managers and to communicate on risks associated with the food chain.

Why Sweden is not in EU? ›

Despite being a part of the European Union, Sweden remains outside the eurozone. The country held a referendum on joining the euro back in 2003, but a majority of the population decided not to adopt the single currency.

Why is Serbia not in the EU? ›

Serbia officially applied for European Union membership on 22 December 2009. Accession negotiations are currently ongoing. The latest report on Serbia's progress criticizes the country for a lack of reforms, issues with rule of law, issues with freedom of the press, as well as disalignment on geopolitical matters.

Why did Britain leave the EU? ›

Austerity. In managing their economy, the EU opted for austerity – resulting in significant problems for countries including Greece and Italy. Professor Whiteley believes austerity did not work, delayed economic recovery both in Europe and Britain and stimulated euroscepticism.

Could Israel join the EU? ›

The European Council has not been asked to take a stance regarding whether or not Israel is a European state, but similar circumstances to Morocco (being geographically outside Europe and without exceptional features such as CoE membership) may preclude its inclusion as a full member into the EU as well.

What 5 countries want to join the EU? ›

EU candidate countries
  • Albania.
  • Bosnia and Herzegovina.
  • Moldova.
  • Montenegro.
  • North Macedonia.
  • Serbia.
  • Türkiye.
  • Ukraine.

Which country is no more member of EU? ›

The United Kingdom, which had acceded to the EU's predecessor in 1973, ceased to be an EU member state on 31 January 2020. No other member state has withdrawn from the EU and none has been suspended, although some dependent territories or semi-autonomous areas have left.

Can Ukraine join NATO during war? ›

Nato membership, carrying with it a commitment from all member countries to protect each other if attacked, has long been a demand from Kyiv. Although Nato agreed in principle in 2008 that Ukraine could be allowed to join, the country has never been given a formal pathway to membership.

What happens if Ukraine joins NATO? ›

If Ukraine were to join NATO, the collective defence principle would mean the whole of the alliance was at war with Russia. The West has been toeing a precarious line when it comes to direct conflict with Moscow, and trying its best to avoid becoming an active participant in the current Ukraine war.

Is Turkey a member of the EU? ›

Relations between the European Union (EU) and Turkey were established in 1959, and the institutional framework was formalised with the 1963 Ankara Agreement. Albeit not officially part of the European Union, Turkey is one of the EU's main partners and both are members of the European Union–Turkey Customs Union.

What are EU GMP particle limits? ›

EU GMP Annex 1 specifies limits of air-borne particles concentration for particle sizes > 0.5 µm and > 5.0 µm. The US FDA requests control of those for 0.5 µm only. There is no evidence that American drugs are worse.

What is Annex 21 to the EU GMP guidelines? ›

This Annex 21 to the EU-GMP Guidelines now sets out the principles and requirements applicable to a Manufacturing and Import Authorisation (MIA) holder importing medicinal products (human and veterinary) across EU/EEA borders.

What is EU GMP Grade A? ›

EU GMP Grade A is approximately equivalent to ISO 14644 Class 5. EU GMP Grade B is approximately equivalent to ISO 14644 Class 5. EU GMP Grade C is approximately equivalent to ISO 14644 Class 7. EU GMP Grade D is approximately equivalent to ISO 14644 Class 8.

Why 0.5 and 5 micron particle count required in pharma? ›

During non viable particle monitoring 0.5 and 5.0 micron particles are measured because most commonly found bacteria range is in between 0.5 to 5.0 micron so this range of particles are the main source of product contamination and can be carried from one area to another area very easily with the air movement.

What is the viable particle count limit as per ISO? ›

The ISO 1 specification for cleanrooms require less than 2 particles greater than 0.3 microns and no particles greater than 1.0 microns per cubic meter.

What is the FDA cleanroom limit? ›

The FDA standard classifies and monitors airborne particles at a single size threshold of ≥ 0.5 μm; EU and PIC/S use two size thresholds: ≥ 0.5 and 5.0 μm.

What is a GMP checklist? ›

A Good Manufacturing Practices (GMP) audit checklist is a tool used by manufacturers to ensure that food, pharmaceutical, medical, and cosmetic products are of consistent quality and in compliance with manufacturing standards.

What is process validation in GMP requirements? ›

FDA conducts GMP validation for cleaning to ensure that no cross-contamination occurs between different batches. Ensuring the precision, accuracy and consistency of analytical tests in very important. A test method must be verified to be acceptable for intended use before it is applied to test the analytical samples.

What are certificates of GMP compliance? ›

The GMP certificate declares that the manufacturer complies with GMP, and the certificate includes a reference to the most recent date of the actual inspection, as well as which activities and under which legislation they have been inspected. A GMP certificate is issued to a site and refers to one specific address.

What is Annex 13 of the GMP guidelines? ›

The revised Annex 13 changes the EU's approach to the management of issues that sit at the boundary between GMP and GCP. These include the two-step release procedure, handling and shipping of investigational medicinal products and contractual arrangements between the trial Sponsor and IMP manufacturer.

What is Annex 15 of GMP? ›

This Annex describes the principles of qualification and validation which are applicable to the facilities, equipment, utilities and processes used for the manufacture of medicinal products and may also be used as supplementary optional guidance for active substances without introduction of additional requirements to ...

What is Annex 11 guidelines? ›

Annex 11 was created to ensure that when a computer is used in place of a manual operation in the manufacture of pharmaceuticals, there is no further risk to limb or paw when it comes to product quality, efficacy, or patent safety. While Annex 11 is not a legal requirement, it is a strongly recommended guideline..

What is Grade and B in GMP? ›

Grade A – A zone for high-risk operations that need the highest level of environmental control. It's equivalent to ISO Class 5, both at rest and in operation. Grade B – A zone for aseptic preparation, filling, and compounding. It's equivalent to ISO Class 5 at rest and ISO Class 7 in operation.

What is the difference between Grade A and Grade B cleanrooms? ›

Grade A is the cleanest and is used for sterile operations. Grade B: This grade provides a background environment to enable aseptic preparation and filling for some grade A zone items. Grade C: Grade C cleanrooms are used to perform less critical activities needed for the non-critical manufacturing stages.

What is the difference between ISO class and EU grade? ›

FDA classifies cleanrooms from ISO 5 to ISO 8. EU classifies cleanrooms from grade A to D. ISO 14644-1 specifies classes of air cleanliness in terms of the number of particles expressed as a concentration in air volume.


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