AstroCel® I HTP high temperature HEPA filter The new standard for dry heat processes Dr.-‐Ing. Marc Schmidt Business Development Manager Pharma EMEA AAF InternaFonal [email protected] +49 175 18 788 78 FIELD OF APPLICATION High temperature processes in ultra clean environments Dry heat sterilizaFon and depyrogenaFon tunnels in the pharmaceuFcal industry. PreparaFon and cleaning High temperature HEPA filter challenges to be miFgated for the ‘hot zone’ Withstanding integrity challenges caused by high variaFons in operaFng temperatures. PrevenFng process contaminaFon from bypass of unfiltered air, leaks or shedding of parFcles. Maintaining ISO 5 / GMP grade A condiFons for guaranteeing sterility of the washed glassware. Reducing required Fme for burn-‐in and heaFng up in order to opFmize process producFvity. Sterile filling and closing AVAILABLE SOLUTIONS OpFon 1. Ceramic sealant and aluminium separators The tradiFonal high temperature HEPA filter for dry heat tunnels. Ceramic sealant Fibreglass medium Ceramic fibre Glass paper Parallel aluminium separators AVAILABLE SOLUTIONS OpFon 1. Ceramic sealant and aluminium separators Well-‐known issues with cracking of the ceramic sealant. Risks associated with ceramic sealant failures • • • • Bypass of unfiltered air, resulFng in process contaminaFon. Uncontrolled shedding of ceramic sealant material into the oven or tunnel, resulFng in process contaminaFon. Expensive unscheduled downFme of the producFon process. PotenFal loss of producFon batches and impac]ul recalls. AVAILABLE SOLUTIONS OpFon 2. ElasFc fibreglass sealant and stainless steel separators The proven superior high temperature HEPA filter for dry heat tunnels. Elas@c fibreglass sealant Fibreglass medium Angular stainless steel corrugated separators AVAILABLE SOLUTIONS Comparison of both soluFons on key parameters Notable differences in the benefit of opFon 2. AstroCel I HTP OpFon 1: Ceramic + aluminium OpFon 2: Elas@c fibreglass + stainless steel 2050 2100 IniFal resistance (Pa) 250 ≤ 250 Burst pressure (Pa) 500 500 Efficiency (EN1882:2009) ≥ 99,95% at MPPS ≥ 99,95% at MPPS Temperature resistance 350 oC conFnuous 350 oC (400 oC 1h peak) HeaFng and cooling rate 100 oC / hour 300 oC / hour FDA 21 CFR-‐211.94 Compliant Compliant ConstrucFon All stainless steel All stainless steel Separators Aluminium Stainless steel Sealant Ceramic Elas@c fibreglass 3 Airflow (m /h) Benchmark test performed on a 610x610x292 mm deep-‐pleat HEPA filter. ASTROCEL I HTP The proven superior high temperature HEPA filter for dry heat tunnels Improved process performance Beneficial Total Cost of Ownership IMPROVED PROCESS PERFORMANCE Best-‐in-‐class high temperature performance to meet sterility requirements High temperature resistance • • 350 oC conFnuous, 400 oC peak (1 hour). FDA 21 CFR-‐211.94 / GMP compliant. H13 efficiency HEPA filter • • H13 efficiency level according to EN1822:2009. ≥ 99,99 at 0,3 µm and ≥ 99,95 at MPPS (confirmed during mulFple heat-‐cycles). Free of silicones • • No risk of siloxane contaminaFon. Guaranteed air quality. All stainless steel frame construcFon, minimizing heat stretching • • • Increased long term heat resistance. Less prone to oxidaFon. Less parFcle shedding. IMPROVED PROCESS PERFORMANCE Best-‐in-‐class high temperature performance to meet sterility requirements Integrated stainless steel sFffener plates and stays • • • Increased sFffness. PrevenFon of pleat winding. Less prone to oxidaFon. Angular stainless steel corrugated separators • • • • • Increased medium pack sFffness. No risk of separator nesFng. Less thermal expansion. Less prone to oxidaFon. Less parFcle shedding. ElasFc fibreglass media sealant • • Avoids integrity breaches by stress cracks. Less parFcle shedding. IMPROVED PROCESS PERFORMANCE Limited risk of parFcle shedding during elevated temperatures Superior performance of AstroCel I HTP • • Significant difference in parFcle shedding properFes and potenFal process contaminaFon. MeeFng ≥ 99,99% at 0,3 µm and ≥ 99,95% at MPPS during efficiency test. IMPROVED PROCESS PERFORMANCE MulFple heat cycles have confirmed a reliable operaFon Test condiFons Pre-‐test Post-‐test Filter dimensions (mm) 610x610x290 610x610x290 IniFal resistance (Pa) 203 203 Efficiency at 0,3 µm 99,99% 99,99% Targets Visual appearance Good Good • • 20 repeated heat cycles. Rapid heaFng and cooling between 40 oC and 350 oC at 2100 m3/h. • • Max. resistance of clean filter ≤ 250 Pa. Class H13 efficiency of ≤ 99,99% at 0,3 µm and ≤ 99,95% at MPPS. Conclusions • • • No significant difference between pre-‐ and post test performance. No damage observed to media or sealant. Normal discoloraFon of product to heat exposure, no significant impact. BENEFICIAL TCO Reliable long term operaFon during lifecycle Low iniFal resistance • • • ≤ 250 Pa at nominal airflow. Lower average energy consumpFon and CO2 equivalents. Reduced energy costs during lifecycle. High dust holding capacity • • Longer filter life, fewer replacements needed, less waste. Reduced energy costs during lifecycle. Durable all stainless steel construcFon with elasFc fibreglass sealant • • • Longer filter life and less waste through replacement. Lower probability of producFon downFme. Reduced risk of premature filter replacement, producFon losses and impac]ul recalls. BENEFICIAL TCO Speedy temperature control for improved operaFonal readiness Superior performance of AstroCel I HTP • • • High airflow rate of 2100 m3/h for 610x610x292 mm, 1440 m3/h for 610x610x150 mm, 870 m3/h for 610x610x84 mm. Possibility for heaFng up to 350 °C with 5 °C/min versus 1,5 °C/min. Note: actual burn-‐in procedure is subject to instrucFons of the equipment manufacturer. ASTROCEL I HTP Standard configuraFon ElasFc fibreglass gasket ASTROCEL I HTP Performance data ExecuFons in 150 mm and 290 mm depth are also available in horizontal mountable versions. ASTROCEL I HTP Performance charts TOTAL PHARMACEUTICAL SOLUTION AAF filtraFon system for dry heat sterilizaFon and depyrogenaFon tunnels Sterile filling and closing PreparaFon and cleaning Various opFons H14 -‐ U15 to EN1822:2009 70 -‐ 120 oC conFnuous Available in different execuFons AstroCel I HTP ≥ 99,99% at 0,3 µm, ≥ 99,95% at MPPS 350 oC conFnuous (400 oC peak) Max. 2100 m3/h for 610x610x290 mm Available in all stainless steel execuFon AstroCel I ≥ 99,995% at MPPS 260 oC conFnuous (260 oC peak) Max. 3000 m3/h for 610x610x292mm Available in stainless steel frame execuFon AAF & NIPPON MUKI’S HT HEPA ATMCU vs. ATMV/ATMVC Nippon Muki ATMCU -‐ AAF AstroCel I HTP Nippon Muki ATMV/ATMVC • ConstrucFon comparable to standard HEPA filters. • Not sharply pleated but bended. • Glass paper filter media pleated. • Glass wool based filter media. • Layers separated by corrugated separators. • Filter media covered by wire mesh. • Volume flow (610x610x290): AstroCel I HTP: 2,100 m3/h ATMCU: 2,100 m3/h • Volume flow (610x610x290): ATMV: 600 m3/h ATMVC: 1,200 m3/h MORE INFORMATION AAF’s air filtraFon soluFons for the pharmaceuFcal industry PharmaceuFcal ApplicaFon Guide Product Quick Reference Guide n elior.com VITCAcel® and MEGAcel® III HEPA filters with NELIOR® membrane m edium: Product leaflet AstroCel I HTP HOW CAN I LEARN MORE? Contact AAF for selecFng the most effecFve and efficient filtraFon system Austria Great Britain The Netherlands Telephone : +43 2236 677 628 E-‐mail : [email protected] Telephone : +44 1670 713477 E-‐mail : airfi[email protected] Telephone : +31 591 664466 E-‐mail : [email protected] Belgium Greece Turkey Telephone : +32 2 426 5451 E-‐mail : [email protected] Telephone : +30 210 6632015 E-‐mail : [email protected] Telephone : +90 216 449 51 6 E-‐mail : [email protected] Finland Italy UAE Telephone : +358 (0)10 2290 700 E-‐mail : sales.fi[email protected] Telephone : +39 031 35 25 311 E-‐mail : [email protected] Telephone : +971 4 339 7688 E-‐mail : [email protected] France KSA Telephone : +33 143 984 223 E-‐mail : [email protected] Telephone : +966 1 2651116 E-‐mail : [email protected] Germany Spain Telephone : +49 208 828423 -‐0 E-‐mail : [email protected] Telephone : +34 916624866 E-‐mail : [email protected] linkedin.com/company/aaf-‐europe plus.google.com/+aafeurope youtube.com/aafinternaFonal slideshare.net/aafeurope
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