Supported standards

List of standards supported by Innoform

Details of the selected standard

Standard type:	ASTM F
Name:	ASTM F 1980
Designation:	Standard-Leitfaden für die beschleunigte Alterung von Sterilbarrieresystemen für Medizinprodukte
Akkreditiert:	nein

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Tests of this standard

Storage test/accelerated ageing in climate chamber (controlled temperature and relative humidity)
Storage tests with or without filling good for estimating the long-term stability of materials and packages. Depending on the requirements, the storage tests can be carried out in a lab drying oven (convection), refrigerator, explosion-proof heating chamber (e. g. solvent-based media,T1 - T3 max. 105° C; T4 max. 70° C), climate chamber (humidity and temperature controlled, temperature and humidity cycles possible). Please select the appropriate method to avoid unnecessary costs. To prepare an offer, we need the following details/information: What type of packaging is to be tested (size, filling volume)? How many packages are to be stored? Are the packages empty or do they have to be emptied before testing? What kind of filling material is involved (CAS no./safety data sheet)? How long should the packages be stored? Under which ambient conditions should the packages be stored (temperature, controlled relative humidity)?

Storage test/accelerated ageing in lab drying oven or refrigerator (controlled temperature)
Storage tests with or without filling good for estimating the long-term stability of materials and packages. The storage tests, depending on the requirements, could be carried out in lab drying oven (convection), refrigerator, explosion-protected heating chamber (e. g. solvent-based media, T1 - T3 max. 105 °C; T 4 max. 70 °C), climate chamber (humidity and temperature controlled, temperature and humidity cycles possible). Please select the appropriate method to avoid unnecessary costs. Tests according to this method serve to accelerate the estimation of material ageing, e.g. also with regard to resistance to chemicals, foodstuffs or other filling materials for long-term applications. This is an assessment of purely technical aspects. For the assessment of food law conformity, please refer to the relevant legal regulations. For initial sampling, we strongly recommend parallel testing under real storage conditions to validate the validity of accelerated ageing tests. To prepare an offer, we need the following details/information: What type of packaging is to be tested (size, filling volume)? How many packages are to be stored? Are the packages empty or do they have to be emptied before testing? What kind of filling material is involved (CAS No./Safety Data Sheet)? How long should the packages be stored? Under which ambient conditions should the packages be stored (temperature, controlled relative humidity)?

storage test/ accelerated aging in explosion protected heating chamber (controlled temperature)
Storage tests with or without filling good for estimating the long-term stability of materials and packages. The storage tests, depending on the requirements, could be carried out in lab drying oven (convection), refrigerator, explosion-protected heating chamber (e.g. solvent-based media,T1- T3 max 105 °C;T 4 max. 70 °C), climate chamber (humidity and temperature controlled, temperature and humidity cycles possible). Please select the appropriate method to avoid unnecessary costs. To prepare an offer we need the following information: What type of packaging should be tested (size, filling volume)? How many packages should be stored? Are the packages empty or do they have to be emptied before testing? Which contents are involved (CAS no./ safety data sheet)? How long should the packages be stored? Under what ambient conditions should the packages be stored (temperature, controlled relative humidity)?

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Contact person

Heike Schwertke

+49 441 94986-14

heike.schwertke@innoform.de