Gillain & Co

Hygienic pipe insulation for controlled environments and cleanrooms in the pharmaceutical, biotech and semiconductor industries

Pipe insulation that releases VOCs and compromises cleanroom classification, or fails FDA or cGMP inspections. Insulation materials that allow bacteria and mould to grow on the surface. These are some of the most common insulation issues in pharmaceutical, biotech and semiconductor production environments — and exactly where T-FIT® Clean offers a solution.

T-FIT® Clean has been specifically developed for cleanrooms and controlled production environments where there can be no compromise in terms of purity, hygiene and compliance.

T-FIT® Clean is manufactured from Zotefoams ZOTEK® F fine-cell closed-cell foam and is the only foam insulation product specification tested under the FM4910 Global Cleanroom Materials Protocol, the international standard for cleanroom materials. It complies with cGMP, FDA and all relevant international standards.

Maximum coverage, easy installation

With a 6.35 mm wall thickness and a modular system of ready-made straight sections, elbows and tees, up to 95% pipe coverage can be achieved, while traditional thick insulation rarely exceeds 75%. Installation is simple, tool-free and fast, even in confined spaces and complex installations.

Purity and outgassing

In a cleanroom, every particle and every molecule released from insulation materials matters. Traditional insulation materials can release volatile organic compounds (VOCs) during temperature fluctuations or CIP cycles, potentially affecting both cleanroom classification and product quality.

T-FIT® Clean is made from ZOTEK® F42HT LS, a closed-cell PVDF foam produced using pure nitrogen as blowing agent — without chemical blowing agents or residual compounds. The result:

• VOC emission: 8.86 µg/g (VDI 2083-P17)
• ISO-AMC class -10 (ISO 14644-8) — independently tested
• No fibres, dust particles or loose particulates
• Virtually odourless

Moisture barrier and corrosion prevention

Moisture inside insulation increases thermal conductivity and can eventually lead to corrosion under insulation. The fully closed-cell structure of T-FIT® Clean provides an exceptional moisture barrier: 6.35 mm T-FIT® Clean has the same water vapour resistance as 40 metres of still air (µ-value: 6,500). Moisture does not reach the piping.

Resistance to mould and bacteria

Microbial growth on insulation materials is considered a non-conformity during any cGMP inspection. The fused surface layer of T-FIT® Clean contains no open pores or cavities where bacteria or mould spores can settle.

Tested according to ASTM G21-15: after 28 days of exposure to five mould species at more than 85% humidity and temperatures between 28–30°C, no growth was detected. Rating: 0/4 — the best possible result.

Resistant to industrial cleaning agents

Cleanrooms are regularly cleaned with aggressive chemicals. T-FIT® Clean was continuously exposed for seven days to six commonly used cleaning agents, including caustic gels, alkaline foam cleaners, acidic detergents and sterile sprays. Result: no degradation, no discoloration and no loss of thermal performance.

Stable across a wide temperature range

T-FIT® Clean remains stable from -80°C to +160°C and withstands both low process temperatures and high CIP cleaning temperatures without any loss of thermal performance throughout the lifetime of the installation.

Fire safety

• Euroclass B - s1, d0 (EN 13501-1) — minimal smoke development, no flaming droplets
• Flame Spread Index 5, Smoke Developed Index 45 (UL723 / ASTM E84)
• FM4910 Specification Tested

T-FIT® Clean delivers the lowest flame, smoke and toxicity ratings of any polymer or elastomer insulation product currently available on the market.

Applications

T-FIT® Clean is suitable for:

• Process piping and utilities in pharmaceutical cleanrooms
• Steam and CIP lines
• Cooling and refrigeration systems
• Buffer tanks and storage tanks
• Heat exchangers
• Water and steam distillation systems
• Cryogenic vessels
• Sterile flexible hoses
• Semiconductor manufacturing and biotechnology laboratories

Certifications

• FM4910 — Specification Tested (Global Cleanroom Materials Protocol)
• ASTM G21-15 — no mould growth after 28 days
• FDA — manufactured from FDA-compliant Kynar® resin
• cGMP — installations have consistently passed FDA inspections
• Euroclass B - s1, d0 (EN 13501-1)
• ISO-AMC class -10 (ISO 14644-8)

Available sizes

T-FIT® Clean is available in three pipe standards, each with ready-made straight sections, elbows and tees:

• ASME BPE — 0.25" to 4.0" OD
• ISO 1127 — DN6 (OD 10.2 mm) to DN80 (OD 88.9 mm)
• DIN 11850 — DN8 (OD 10 mm) to DN80 (OD 85 mm)