Containment Glossary.

Glossary.

What does containment mean? What is the difference between SUT and MUT and what does that mean? Do I need REACH?

The containment packaging industry is peppered with abbreviations, technical terms and incomprehensible words. It is not easy to always understand everything. We at IDF understand this and want our customers to have the best possible knowledge of the product. You will find the answers to your questions here, in our containment glossary.

A

Acidification Potential

The acidification potential is one of the influencing categories in a life cycle study (see the term "life cycle study"). This key figure quantifies the acidification of terrestrial and aquatic ecosystems based on SO2 equivalents, i.e. based on a comparison with the influence of sulphur dioxide on acidification during the production process. The lower this value, the lower the risk of acid rain and the associated environmental damage.

In a life cycle study in the context of process and filling technology, it was found that single-use technology (see term "SUT"), such as the containment packaging from IDF GmbH & Co. KG, has around 70% less influence on acidification than Multi-Use Technology (see term "MUT").

ADI (Acceptable Daily Intake)

The ADI is a key figure for the maximum permissible amount of active substance that a person can be exposed to in one day. If the RDI (see term "Real Daily Intake") exceeds the ADI, the person who has come into contact with the active ingredient is at risk. In contrast to the OELs (see term “Occupational Exposure Limits”), the ADI is given in milligrams of the active ingredient per kilogram of body weight.

IDF GmbH & Co. KG offers individually adapted containment packaging for your carrier systems, which means that the RDI can be reduced to a minimum. In addition to a high level of product protection, containment packaging can also be used in reference to personal protection.

Antistatic agents

Antistatic agents are substances that, when added as an additive, prevent or weaken the static charge on objects.

APCPPE (Assessing the Particulate Containment Performance of Pharmaceutical Equipment)

The APCPPE, formerly SMEPAC, is a guide for the uniform evaluation of containment systems, which was published in 2004 by the ISPE (International Society for Pharmaceutical Engineering). The guidelines contained are continuously being evaluated and adjusted if necessary. In particular, the containment systems should be validated in relation to their tightness and use in operation.

The film packages offered by IDF GmbH & Co. KG are an essential part of fulfilling the guidelines. We can record your requirements for the carrier system you are using and find the most sensible individual solution.

AR (Abiotic Resource Depletion)

The abiotic resource depletion is one of the influencing categories in a life cycle study (see the term "life cycle study"). This key figure quantifies the number of abiotic resources (in megajoules) consumed during the production process. Abiotic resources are finite, non-renewable resources, e.g. stones, earth, ores, fossil fuels such as crude oil, coal, natural gas and unused raw materials.

In a life cycle study in the context of process and filling technology, it was found that the resource depletion in the production of single-use technology (see term "SUT"), such as the containment packaging from IDF GmbH & Co. KG, is around 59% lower than compared to Multi-Use Technology (see term "MUT").

C

CIP (Clean In Place)

CIP (clean in place) is a method for cleaning process engineering systems in which the system is cleaned on the surfaces in contact with the product without dismantling. This can reduce cleaning times and costs as well as waste products. This contributes to compliance with the prescribed hygiene standards. The cleaning results of CIP technologies show very good reproducibility.

IDF GmbH & Co. KG sells a wide range of fixed and rotating nozzles that can be used to efficiently clean containers from the inside.

Closed Systems

Closed systems are machines or equipment that use containment solutions for critical processes such as filling, dosing or cleaning and thus prevent external influences. The effect of such closed systems is described in more detail under the term “containment”.

The containment solutions offered by IDF GmbH & Co. KG provide you with an efficient way of implementing a closed system in your filling processes and thus preventing contamination of the goods to be filled.

Containment

In the context of the chemical, pharmaceutical and food industries, one speaks of containment when it comes to the "containment" of certain substances.

This containment is intended to achieve two main goals: product protection and personal protection. Product protection means that the product (e.g. an active ingredient in the pharmaceutical industry) should be protected from contamination by foreign substances from the environment. However, since dangerous substances are often involved in the above-mentioned industries, personal protection is equally important. Therefore, the escape of these substances from the production process should be prevented.

IDF GmbH & Co. KG enables containment in your filling processes using so-called containment packaging. These save time in your production process. In addition, they are also more environmentally friendly in various areas compared to alternative products such as stainless steel containers.

E

EP (Eutrophication)

Eutrophication is one of the influencing categories in a life cycle study (see the term "Life Cycle Study"). This key figure quantifies the undesired increase in nutrients in a body of water during the product process, measured using the phosphate equivalent (PO4 eq.). This increase in nutrients is undesirable because it promotes useless and harmful plant growth.

In a life cycle study in the context of process and filling technology, it was found that the influence on the eutrophication from single-use technology (see term "SUT"), such as the containment packaging from IDF GmbH & Co. KG, is around 93% lower compared to the influence from Multi-Use Technology (see term "MUT").

F

FDA (Food and Drug Administration)

The FDA is a federal agency of the US-Department of Health and Human Services that controls all food and drugs traded in the US. This also includes all imports, which is why the guidelines and regulations of the US authorities are important for German manufacturers, too. Only companies that are FDA-compliant and whose materials are certified accordingly are allowed to enter the US market.

The containment solutions from IDF GmbH & Co. KG help you to meet the requirements of the FDA quickly and efficiently.

G

GMP (Good Manufacturing Practice)

GMP conformity is understood to mean the fulfilment of guidelines in the production of drugs and active ingredients, but also for cosmetics, food and animal feed. Quality assurance plays a central role in pharmaceutical production and the food industry since deviations in quality have a direct impact on the health of consumers. A GMP-compliant quality management system is used to ensure product quality and to fulfil the mandatory requirements for commercialisation of the health authorities.

In cooperation with professional partners, IDF GmbH & Co. KG sell process engineering equipment and filling systems that enable you to comply with GMP guidelines.

GWP (Global Warming Potential)

The global warming potential is one of the influencing categories in a life cycle study (see the term "life cycle study"). This indicator quantifies the relative contribution of a chemical compound to the greenhouse effect, and thus to global warming, during the production process. This is measured in the kilograms of CO2 generated, usually over 100 years.

In a life cycle study in the context of process and filling technology, it was found that single-use technology (see term "SUT"), such as the containment packaging from IDF GmbH & Co. KG, had around 35% lower global warming potential than multi-use technology (see term "MUT").

L

LDPE (Low Density Polyethylen) / PE-LD

Polyethene is a semi-crystalline, thermoplastic material produced by the polymerisation of ethene and belongs to the group of polyolefins. In contrast to PVC, polyethene consists only of hydrogen and carbon, so that it burns to carbon dioxide and water vapour in the waste incineration process and has a comparatively good ecological balance.

Polyethene has a high resistance to attacks by acids, alkalis and other chemicals, which is why it is used in the containment solutions from IDF GmbH & Co. KG and enables you to have a safe filling process.

Life Cycle Study

A life cycle study determines the consumption of energy and resources of a product in an entire production process and then quantifies the effects on the environment. The production process means the raw material extraction, the production up to the product use and the product disposal. The aim here is to find the best of several alternative production processes to select a specific product accordingly. Defining the functional units is essential for a life cycle study, as it is only based on individual products, allowing them to be compared.

In a life cycle study in the context of process and filling technology, it was found that single-use technology (see term "SUT"), such as the containment packaging from IDF GmbH & Co. KG, are significantly more environmentally friendly than multi-use technology (see term "MUT").

M

Migrating Antistatic

A migrating antistatic is a subgroup of the antistatic (see term “antistatic”). As an additive, the material offers improved discharge properties, but is sensitive to external influences and can therefore rub off (“migrate”).

MUT (Multi Use Technology)

In-process and filling technology, a distinction is made between single-use technology (SUT) and multi-use Technology (MUT). SUT are technologies that are disposed of after a single-use, including containment packaging. MUT are technologies that are used multiple times by going through a complex cleaning process, such as stainless-steel containers.

Despite the single-use and bad image of plastic, the containment solutions offered by IDF GmbH & Co. KG are significantly more environmentally friendly than stainless steel containers in various ways shown in a life cycle study on the two technologies shows.

O

OEB (Occupational Exposure Band)

OEB classes are used for classification according to the specified OEL values (see term OEL). The following list shows the limits defined for the individual OEB classes:

- OEB class 1:> 1000 µg / m³

- OEB class 2: 100 - 1000 µg / m³

- OEB class 3: 10 - 100 µg / m³

- OEB class 4: 1 - 10 µg / m³

- OEB class 5: 0.2 - 1 µg / m³

- OEB class 6: <0.2 µg / m³

A substance with an OEL value of 3 µg / m³ therefore corresponds to OEB class 4. The filter system must meet different requirements according to this class. Open / semi-open systems are permitted for OEB classes 1 to 2, whereas OEB 3 to 5 systems with primary containment are required.

IDF GmbH & Co. KG provides you with individually adapted containment packaging for your carrier systems in OEB classes 2-5 at any time.

OEL (Occupational Exposure Limit)

The suitability of a filling system for certain active ingredients depends, among other things, on previously defined OEL values. These quantify the amount of active substance per standard cubic meter of breath that a person can be exposed to for eight hours without their health being impaired. The firmly defined values for OELs are assigned to so-called OEB classes (see term OEB) to be able to carry out a simple classification of the filling systems. For example, a substance with an OEL value of 3 µg / m³ is assigned to OEB class 4. Process and filling systems that handle this substance must be designed following this classification.

IDF GmbH & Co. KG can provide you with individually adapted containment packaging for your carrier systems in OEB classes 2-5 at any time.

R

RDI (Real Daily Intake)

The RDI is a measure of the actual amount of active substance that a person is exposed to over a normal working day. The RDI must not exceed a certain upper limit for particular substances in order not to endanger human health. This upper limit is also referred to as the ADI (see term "Acceptable Daily Intake").

IDF GmbH & Co. KG provides you with individually adapted containment packaging for your carrier systems with a technology with which the RDI can be reduced to a minimum. In addition to a high level of product protection, containment packaging also represents high standard personal protection.

REACH (Registration, Evaluation, Authorisation of Chemicals, EG Nr. 1907/2006)

REACH is a regulation of the European Union that came into force on 1^st June 2007. It aims to protect people and the environment from the risks posed by chemicals, whilst at the same time, increasing the competitiveness of the chemical industry in the EU.

The main rule is that the production or EU import of chemicals is subject to registration starting from a ton per year. This registration is not only time-consuming, but it is also expensive for the production company. However, for intermediate products, there is an exception to the rule which involved less complex registration which allows significantly lower costs but under strict control conditions.

With its containment solutions, IDF GmbH & Co. KG offers the ideal product for fulfilling the REACH regulations. Due to the high level of personal and product protection (see term "containment"), the criteria for the strictly controlled conditions can be met, so that the registration process is much more affordable for you. Our containment solutions are highly flexible and can be adapted to your requirements.

S

SMEPAC (Standardised Measurement for Equipment Particulate Airborne Concentrations)

The outdated term, see term "APCPPE" (Assessing the Particulate Containment Performance of Pharmaceutical Equipment)

SUT (Single Use Technology)

In process and filling technology, a distinction is made between single-use technology (SUT) and multi-use technology (SUT).

SUT are technologies that are items disposed of after a single-use and includes containment packaging.

MUT are technologies that are used multiple times by going through a complex cleaning process, such as stainless-steel containers.

W

Water Footprint

The water footprint is one of the influencing categories in a life cycle study (see the term "Life Cycle Study"). This key figure quantifies the amount of water consumed (in m³) during the production process. This has an influence on the availability of fresh water in the region, which can have consequences for people, flora and fish.

In a life cycle study in the context of process and filling technology, it was found that single-use technology (see term "SUT"), such as the containment packaging from IDF GmbH & Co. KG, consumes around 95.5% less water than multi-use technology (see the term "MUT").

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