QUALITY
Starting from 1999 FF.GI Srl have a quality system certified by an external association that complies to UNI EN ISO 9001:2015 regulations.The adopted SGQ involves all the production process that are strictly controlled by the applications of the regulation terms. Aspiring to a continuate improvement FF.GI. Srl have always listened to their customer needs taking every request as a chance of improving products and services.
In order to reach the technical, qualitative and normative request of our customers FF.GI Srl have empowered its informatic systems to control and elevate the quality of all the production processes:
- Emission of updated Inspection Reports (dimension control) with sampling plan according to both FF.GI srl and customers specifications thanks to our highly sophisticated production site.
- Emission of UNI EN 10204 2.1 - 2.2 - 3.1 certifications on raw materials.
- Capability of monitoring the production process with real-time update on the situation.
- Back tracking thanks to the production lot number, mandatory for some legal instances.
- Non-invasive marking on the finished product, with lot number or other useful information.
CONFORMITY & HOMOLOGATIONS
FF.GI. Srl have developed a series of materials that complies to the main legislations and obtained the following homologations:
FLON-CHEM 1121 – Virgin PTFE Premium Grade:
• USP CLASS VI 121°c compliance: Cytotoxicity elution test according to USP <87>; USP biological test according to USP <88>;
• 3-A Sanitary standard compliance for multiple use plastic materials version 20-27;
• Food contact compliance - MOCA/FCMs: FDA 21 cfr. § 177.1550; Regulation 1935/2004-CE; Regulation 10/2011-UE; D.M. 21/03/1973
(S.O. GU n. 104 del 20/04/1973) e D.P.R. n.777 del 23/08/1982.
FLON-CHEM 1075 – Modified PTFE Premium Grade:
• USP CLASS VI 121°c compliance: Cytotoxicity elution test according to USP <87>; USP biological test according to USP <88>;
• Food contact compliance – MOCA/FCMs: FDA 21 cfr. § 177.1550; Regulation 1935/2004-CE; Regulation 10/2011-UE; D.M. 21/03/1973
(S.O. GU n. 104 del 20/04/1973) e D.P.R. n.777 del 23/08/1982.
FLON-CHEM 1000 – Virgin PTFE Standard Grade:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1001 – PTFE + 25% GLASS filled:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1015 – Modified PTFE + 25% GLASS filled:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1011 PINK – Modified PTFE + SILICA filler:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1050 BLUE – Modified PTFE + hollow glass microspheres:
• USP CLASS VI 121°c compliance: Cytotoxicity elution test according to USP <87>; USP biological test according to USP <88>;
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1045 SILVER – Modified PTFE + 50% passivated stainless steel:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1022 BLACK – PTFE antistatic:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1100 J – PTFE + polyimide:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1006 FKM:
• USP CLASS VI 121°c compliance: Cytotoxicity elution test according to USP <87>; USP biological test according to USP <88>;
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM MULTISOFT – Expanded multidirectional PTFE:
• Food contact compliance: FDA 21 cfr. § 177.1550
• TA-Luft VDI 2440
FLON-CHEM 1121 – Virgin PTFE Premium Grade:
• USP CLASS VI 121°c compliance: Cytotoxicity elution test according to USP <87>; USP biological test according to USP <88>;
• 3-A Sanitary standard compliance for multiple use plastic materials version 20-27;
• Food contact compliance - MOCA/FCMs: FDA 21 cfr. § 177.1550; Regulation 1935/2004-CE; Regulation 10/2011-UE; D.M. 21/03/1973
(S.O. GU n. 104 del 20/04/1973) e D.P.R. n.777 del 23/08/1982.
FLON-CHEM 1075 – Modified PTFE Premium Grade:
• USP CLASS VI 121°c compliance: Cytotoxicity elution test according to USP <87>; USP biological test according to USP <88>;
• Food contact compliance – MOCA/FCMs: FDA 21 cfr. § 177.1550; Regulation 1935/2004-CE; Regulation 10/2011-UE; D.M. 21/03/1973
(S.O. GU n. 104 del 20/04/1973) e D.P.R. n.777 del 23/08/1982.
FLON-CHEM 1000 – Virgin PTFE Standard Grade:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1001 – PTFE + 25% GLASS filled:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1015 – Modified PTFE + 25% GLASS filled:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1011 PINK – Modified PTFE + SILICA filler:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1050 BLUE – Modified PTFE + hollow glass microspheres:
• USP CLASS VI 121°c compliance: Cytotoxicity elution test according to USP <87>; USP biological test according to USP <88>;
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1045 SILVER – Modified PTFE + 50% passivated stainless steel:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1022 BLACK – PTFE antistatic:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1100 J – PTFE + polyimide:
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM 1006 FKM:
• USP CLASS VI 121°c compliance: Cytotoxicity elution test according to USP <87>; USP biological test according to USP <88>;
• Food contact compliance: FDA 21 cfr. § 177.1550
FLON-CHEM MULTISOFT – Expanded multidirectional PTFE:
• Food contact compliance: FDA 21 cfr. § 177.1550
• TA-Luft VDI 2440
Other conformity declarations are available, on customer request, according to the main European regulations:
• REACH 1907/2006 EC european regulation: “Registration, Evaluation and Authorisation of Chemicals”
• RoHS 2011/65/EU, ADI-free (free from Animal Derived Ingredients), and other european directives about the regulation of substance hazardous for health
• Guidelines for the correct disposal of packaging
• REACH 1907/2006 EC european regulation: “Registration, Evaluation and Authorisation of Chemicals”
• RoHS 2011/65/EU, ADI-free (free from Animal Derived Ingredients), and other european directives about the regulation of substance hazardous for health
• Guidelines for the correct disposal of packaging