EIGAnews - 2020-08-31

2020 08 31

Dear Members,

We were informed of administrative non-conformances relating to welds at some brazed aluminium heat exchangers. You can read the Position Paper and Briefing Note that IGC issued after investigation.

When Covid19 hit Europe, EIGA requested that an exceptional temporary derogation to ADR be issued. Please be advised this derogation is valid until 31st August 2020 only.

Last week, the International Harmonisation Council was held. It was a virtual meeting, but the good international collaboration was reconfirmed.

Happy reading,

Philippe Cornille, Gen.Sec. EIGA

International Harmonisation Council

01

EIGA actively participates in the International Harmonisation Council (or IHC). It is indeed in the interest of enhanced safety, as well as improved efficiency, that industry publications are consistent wherever in the world gases are produced, distributed, or used. Today, over of 60 EIGA publications are harmonised.

Last week, EIGA hosted (virtually) the 47th IHC. The programme for drafting or reviewing harmonised publications was reviewed. Particularly in the light of the Yima City incident, it was identified which publications require early review to incorporate lessons learned.

Click here to read more on IHC.

EIGA Councils

IGC

02

Sumitomo Precision Products Fabricated Brazed Aluminium Heat Exchangers (PP 44/20 & BN 28/20 & GasWorld article)

A number of industrial gas companies purchase brazed aluminium heat exchangers (BAHXs) from Sumitomo Precision Products (SPP) for use in air separation units and similar plants. SPP made EIGA members aware of administrative non-conformances relating to welds that form part of the manufacture of some BAHXs.

Based on the evaluation of its members’ operating experience, EIGA believes that the SPP supplied brazed aluminium heat exchangers are reliable and safe. SPP’s reported nonconformance does not affect the mechanical integrity of these heat exchangers and no new actions are needed for continued safe operation.

See here for the Position Paper.

Or see this GasWorld article.

A Briefing Note was also published on the subject (for members only).

03

Temporary Covid19 derogation on periodic testing expires

In April this year EIGA published TB35 "COVID-19 - Multilateral Agreement M326 - Periodic Inspection and test of Pressure Receptacles for the Carriage of Gases of Class 2", requesting an exceptional temporary derogation to ADR be issued to assist in the availability of pressure receptacles for primarily medical oxygen, but also to other gases related to the medical supply chain.

The derogation was granted via a Multilateral Agreement MLA 326 and is valid until 31st August 2020.

Please note this MLA 326 is unlikely to be renewed, therefore, the EIGA members should ensure that their cylinders are not sent out untested after the 31st August MLA expiry date.

04

Doc 13/20 - Oxygen Pipeline and Piping Systems

(Harmonised publication, revision of Doc 13/12) Oxygen pipeline systems developed over many decades in the various countries of Europe, North America, and in other geographies have shown good and comparable safety records, although company practices show many differences in design and operations. Some national authorities have also introduced legislation that is mandatory for the operators in those countries.

The scope of this publication is for metal oxygen pipelines, distribution piping systems, and gaseous oxygen piping on an air separation plant external to the coldbox. The scope is limited to gaseous oxygen with a temperature range between –30 °C and 200 °C (–22 °F and 400 °F), pressures up to 21 MPa (3000 psi) and a dew point of –30 °C (–22 °F) or less depending on local conditions.

05

Doc 127/20 - Bulk Liquid Oxygen, Nitrogen and Argon Storage Systems at Production Sites

(revision of Doc 127/13) The increase in recent years in the size and production capacity of air separation plants has led to a corresponding increase in the capacity of cryogenic liquid storage installations at production sites. Therefore, it has become more important to consider the potential hazards associated with cryogenic liquid, the consequences and effects on the local environment of a major release of liquid, and the preventive measures required.

This publication specifically covers storage installations on production sites where the storage tank is flat-bottom constructed, is connected to the production process plant, and the individual tank capacity is greater than 125 000 litres.

06

TP 08/20 - Road Vehicle Emergency and Recovery

(revision of TP 08/03) This Training Package has been produced to assist member companies in the training of personnel on the contents of the EIGA document 81 “Road Vehicle Emergency and Recovery”. It provides additional detail and information to support the above document.

It is divided into 10 chapters, so that they can be used separately in order to be targeted to different audiences. The links to the 10 chapters (members only) are :

Road Vehicle Emergency and Recovery - Chapt 1

Road Vehicle Emergency and Recovery - Chapt 2

Road Vehicle Emergency and Recovery - Chapt 3

Road Vehicle Emergency and Recovery - Chapt 4

Road Vehicle Emergency and Recovery - Chapt 5

Road Vehicle Emergency and Recovery - Chapt 6

Road Vehicle Emergency and Recovery - Chapt 7

Road Vehicle Emergency and Recovery - Chapt 8

Road Vehicle Emergency and Recovery - Chapt 9

Road Vehicle Emergency and Recovery - Chapt 10

07

TP 36/19 REV - Electronic Specialty Gases Near Miss Incidents

(Harmonised publication, rev of TP 36/13) As a part of a programme of harmonisation of industry standards, EIGA has adapted a publication developed by Japan Industrial and Medical Gases Association (JIMGA) as a globally harmonised publication. Today, a wide variety of Electronic Specialty Gases (ESGs) are used to manufacture semiconductors, liquid crystals, solar cells etc. The rapid progress of process technology is also leading to the development of new processes using new ESGs.

The safe use of both conventional and new ESGs requires a good understanding of their properties as well as safe and proper handling techniques. In practice, however, it appears that information on ESGs is often not communicated in accurate, clear or easy-to-understand ways to people who need this information.

This Training Package (members only) is presented for use in safety discussions and training sessions with member employees involved in these industries. Case examples of near miss incidents are presented in this Training Package, with illustrations to enable fast understanding of lessons to be learned.

MGC

08

Temporary Covid19 derogation on periodic testing expires

In April this year EIGA published TB35 "COVID-19 - Multilateral Agreement M326 - Periodic Inspection and test of Pressure Receptacles for the Carriage of Gases of Class 2", requesting an exceptional temporary derogation to ADR be issued to assist in the availability of pressure receptacles for primarily medical oxygen, but also to other gases related to the medical supply chain.

The derogation was granted via a Multilateral Agreement MLA 326 and is valid until 31st August 2020.

Please note this MLA 326 is unlikely to be renewed, therefore, the EIGA members should ensure that their cylinders are not sent out untested after the 31st August MLA expiry date.

09

EIGA observer at EUDAMED

EIGA has been granted Observer status in the EUDAMED sub-group of the Medical Device Coordination Group (MDCG) for a period of five years starting from 1 September 2020. Two experts from WG15 Medical Equipment were accepted to participate.

This working group will assist and advise the MDCG on policy and technical matters related to the establishment, management and maintenance of the European Database on Medical Devices (EUDAMED), including the implementation and application of the relevant provisions of the MDR and IVDR. In doing so, the Subgroup will support the development process of the necessary specifications and technical functionalities related to EUDAMED

10

Doc 232/20 - Microbiologiocal Quality of Medical and Food Gases Review - Scientific Report

For the assessment of the microbiological quality of food and medical gases there are no specific normative references, either for parameters to detect and for the analytical aspects, or for limits to be respected. However, there is a reference in the European Pharmacopoeia with parameters and limits for non-sterile products for inhalation use, that fit well with the topic.

The scope of this scientific report specifically covers the microbiological quality requirements for gases used for medical, pharmaceutical and food applications. It covers compressed and liquefied gases supplied in high pressure cylinders, and cryogenic liquids supplied by tankers into bulk storage tanks or in portable cryogenic containers.

It covers the quality of the gas up to the point of delivery into the customer’s storage tank or at the outlet valve in high pressure cylinders or portable cryogenic containers. It does not address the quality of the gas once it has been distributed to the usage point via the customer’s pipeline system. It does not cover medicinal or food grade gases that are produced using either Pressure Swing Adsorption (PSA) or Air compressing plants on the customer’s premises.

This publication relates only to the microbiological quality of the gas and does not cover the external condition of the container.

This scientific report is intended as support to the matching Technical Bulletin TB02 (see below), and is for use by EIGA Members and national regulatory authorities involved in the regulation of manufacturing of medical, pharmaceutical and food gases.

11

TB 02/20 - Microbiological Quality of Medical, Pharmaceutical and Food Grade Gases

(revision of TB 02/12) This Technical Bulletin details EIGA’s position concerning the microbiological quality of gases used in medical, pharmaceutical and food applications. It is intended to assist in providing answers to both end users of the gases and to Regulatory Authorities questioned about the microbiological quality of gases.

Analysis studies, carried out by the gases industry, have shown that the levels of microbiological contamination of compressed, liquefied and cryogenic gases are well below the levels specified in the European Pharmacopoeia Chapter 5.1.4.

Analytical measurement data confirm that the microbiological quality of gases are well below the European Pharmacopeia acceptance criteria for non-sterile products for inhalation use.

Based on the review of the above documents it is not required to monitor the quality of gases compared to the acceptance limits of the European Pharmacopoeia.

12

TB 36/20 - Analysis of Fire Incidents in Homecare Oxygen Therapy Based on Data Review and Literature

The combination of smoking or open flames together with oxygen is dangerous and can lead to fires. Patients receiving oxygen therapy at home, sometimes do not follow the safety instructions related to using oxygen safely and, as a result, fires may occur.

This Technical Bulletin provides advice to Homecare Service Providers on the mitigation of fires in homecare oxygen therapy based on both a literature review and an analysis of the occurrences of oxygen fire incidents at homecare patients recorded by EIGA members.

REC

13

EIGA applied to become member of the Platform on Sustainable Finance.

Though the number of seats in the Platform on Sustainable Finance are very limited (and EIGA standing only a minute chance for success), EIGA is convinced we could add value to the Platform's mission (i.e. "to advise the European Commission on several tasks related to sustainable finance and the development of the EU taxonomy, as stipulated in the EU Taxonomy Regulation").

Our decarbonisation vision is two-fold: on one side reducing emissions associated with the production of industrial gases themselves and, on the other side, using industrial gases to improve efficiency and reduce emissions in other sectors.

EIGA felt compelled to apply for membership. A dossier was prepared by AHG-R.4 and consecutively submitted on July 16th. Feel free to reach out to p.cornille@eiga.eu for more info.

14

EIGA supports the European Clean Hydrogen Alliance

The European Clean Hydrogen Alliance brings together industry, national and local public authorities, civil society and other stakeholders. It is strongly anchored in the hydrogen value chain, covering renewable and low-carbon hydrogen from production via transmission to mobility, industry, energy, and heating applications.

EIGA applied to co-sign the Declaration.

SAC

15

Doc 191/20 - Calculation of Emissions from a Nitrous Oxide Plant

This publication provides details on nitrous oxide emissions from a nitrous oxide plant. The user may adapt this information with their information specific to their own plant and obtain an estimate of the emissions to air.

The basic philosophy behind the publication is the minimisation of emissions, nuisance and wastes of any kind and their disposal as it is stated in ISO 14001, Environmental Management Systems -- Requirements with Guidance for Use

16

TP 60/20 - Perlite Management (Perlite and Deperliting Operations)

Perlite is a non-toxic and non-flammable product used extensively to insulate cryogenic equipment, and particularly coldboxes. However, the nature of the material and the large quantities involved require the use of special operations, handling, and safety procedures. This Training Package provides guidance for reducing the risks of unplanned perlite releases and incidents that could have potential for personal injury, property damage, downtime, and environmental impact. This Training Package supplements the information and guidance given in EIGA Doc 146, Perlite Management.

It covers the use of perlite in cryogenic coldboxes and cryogenic bulk storage vessels and focuses on safety, perlite handling procedures, and management of perlite in the event of release, and is intended for use by industrial gas plant manufacturers, owners, and operators of facilities that utilize and maintain perlite as an insulation medium for cryogenic equipment.

17

Info TS 13/20 - Managing Driver Fatigue

Fatigue can affect all people in their working environment to varying levels. Driving is a complex mental and physical task requiring sustained levels of concentration and skill to maintain maximum performance. No driver can afford to be fatigued nor can anyone else.

The purpose of this publication is to provide training topics and recommendations that can help to avoid situations that affect drivers in their daily lives and can make them fatigued. It gives guidance on what to consider when creating a fatigue management system.

18

TP 36/19 REV - Electronic Specialty Gases Near Miss Incidents

(Harmonised publication, rev of TP 36/13) As a part of a programme of harmonisation of industry standards, EIGA has adapted a publication developed by Japan Industrial and Medical Gases Association (JIMGA) as a globally harmonised publication. Today, a wide variety of Electronic Specialty Gases (ESGs) are used to manufacture semiconductors, liquid crystals, solar cells etc. The rapid progress of process technology is also leading to the development of new processes using new ESGs.

The safe use of both conventional and new ESGs requires a good understanding of their properties as well as safe and proper handling techniques. In practice, however, it appears that information on ESGs is often not communicated in accurate, clear or easy-to-understand ways to people who need this information.

This Training Package (members only) is presented for use in safety discussions and training sessions with member employees involved in these industries. Case examples of near miss incidents are presented in this Training Package, with illustrations to enable fast understanding of lessons to be learned.

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