The document discusses heating, ventilation and air conditioning (HVAC) systems for clean rooms and pharmaceutical facilities. It describes different options for return air locations and airflow schematics. Recirculation of air is acceptable if HEPA filters are used to prevent cross-contamination. Systems using 100% fresh air are recommended when toxic products are involved to avoid recirculating air with contaminants. Energy recovery wheels should generally not be used in multi-product facilities due to contamination risks.
Original Description:
Low Level Return or Exhaust Air Grilles Are Usually Preferred
The document discusses heating, ventilation and air conditioning (HVAC) systems for clean rooms and pharmaceutical facilities. It describes different options for return air locations and airflow schematics. Recirculation of air is acceptable if HEPA filters are used to prevent cross-contamination. Systems using 100% fresh air are recommended when toxic products are involved to avoid recirculating air with contaminants. Energy recovery wheels should generally not be used in multi-product facilities due to contamination risks.
The document discusses heating, ventilation and air conditioning (HVAC) systems for clean rooms and pharmaceutical facilities. It describes different options for return air locations and airflow schematics. Recirculation of air is acceptable if HEPA filters are used to prevent cross-contamination. Systems using 100% fresh air are recommended when toxic products are involved to avoid recirculating air with contaminants. Energy recovery wheels should generally not be used in multi-product facilities due to contamination risks.
low level return or exhaust air grilles are usually preferred.
however, where this is not possible, a higher
air change rate may be needed to achieve a specified clean area classification, e.g where ceiling return air grilles are used.
there may be alternative locations for return air. for example, referring to Fig 4, room D (low-level return air) and room E (ceiling return air).
The airflow schematics of two systems (Fig 4 and 5) indicate air-handling units with return air or recirculated, having a percentage of fresh air added. Fig 5 is schematic diagram of an air-handling system serving rooms with horizontal unidirectional flow, vertical unidirectional flow and turbulent flow, for rooms A, B and C, respectively.
The airflow diagram in Fig 4 is an example of a typical system with a lower clean area classification.
Recirculation system
There should be no risk of contamination or cross-contamination (including by fumes and volatiles) due to recirculation of air.
Depending on the airbone contaminants in the return-air system it may be acceptable to use recirculated air, provided that HEPA filters are installed in the supply air stream to remove contaminants and thus prevent cross-contamination. The HEPA filters for this application should have an EN1822 classification of H13. HEPA filters may not be required where the air-handling system is serving a single product facility and there is evidence that cross-contamination would not be possible. Recirculation of air from areas where pharmaceutical dust is not generated such as secondary packing, may not require HEPA filters in the system HEPA filters may be located in the air-handling unit or placed terminally. Air containing dust from highly toxic processes should never be recirculated to the HVAC system. Tingkat pengembalian udara yang rendah biasanya paling disukai . Namun, di mana hal ini tidak mungkin ,karena mungkin tingkat pertukaran udara yang lebih tinggi diperlukan untuk mencapai klasifikasi area bersih spesifik.
mungkin ada lokasi alternatif untuk pengembalian udara . misalnya , mengacu pada Gambar 4 , ruang D ( tingkat rendah pengambilan udara) dan ruang E ( langit-langit pengembalian udara) .
skema aliran udara dari dua sistem ( Gambar 4 dan 5 ) menunjukkan unit penanganan udara dengan udara kembali atau diresirkulasi , memiliki persentase udara segar ditambahkan . Gambar 5 adalah diagram skematik dari sistem penanganan udara yang melayani kamar dengan aliran horizontal searah , arus searah vertikal dan aliran turbulen , untuk kamar A , B dan C , masing-masing.
Diagram aliran udara pada Gambar 4 adalah contoh dari sistem yang khas dengan klasifikasi daerah bersih yang lebih rendah.
sistem resirkulasi
Seharusnya tidak ada resiko kontaminasi atau kontaminasi silang ( termasuk oleh asap dan volatil ) karena resirkulasi udara .
Tergantung pada kontaminan airbone dalam sistem return- udara mungkin dapat diterima untuk menggunakan udara disirkulasikan, asalkan filter HEPA dipasang dalam aliran pasokan udara untuk menghilangkan kontaminan dan dengan demikian mencegah kontaminasi silang . The filter HEPA untuk aplikasi ini harus memiliki klasifikasi EN1822 dari H13 . Filter HEPA mungkin tidak diperlukan dimana sistem penanganan udara melayani fasilitas produk tunggal dan ada bukti bahwa kontaminasi silang tidak akan mungkin. Resirkulasi udara dari daerah di mana debu produk farmasi tidak dihasilkan seperti pengemasan sekunder, mungkin tidak memerlukan filter HEPA dalam sistem Filter HEPA mungkin berlokasi di unit penanganan udara atau ditempat beresiko Air yang mengandung debu dari proses yang sangat beracun tidak boleh diedarkan kembali ke sistem HVAC.
Full fresh-air systems
Fig 6 indicates a system operating on 100% fresh air and would normally be used in a facility dealing with toxic products, where recirculation of air with contaminants should be avoided.
The required degree of filtration of the exhaust air contaminants and local environmental regulations.
Energy recovery wheels should normally not be used in multiproduct facilities. When such wheels are used they should not become a source of possible contamination (see Fig 7). NOTE: alternatives to the the energy-recovery wheels, such as cross over plate heat exchangers, may be used in multi product facilities.
The potential for air leakage between the supply air and exhaust air as it passes through the wheel should be prevented. The relative pressures between supply and exhaust air systems should be such that the exhaust air system operates at a lower pressure than the supply system.
Sistem udara segar penuh
Gambar 6 menunjukkan sistem operasi pada 100% udara segar dan biasanya akan digunakan di fasilitas berurusan dengan produk-produk beracun, di mana resirkulasi udara dengan kontaminan harus dihindari.
Tingkat penyaringan yang digunakan tergantung pembuangan kontaminan udara dan peraturan lingkungan setempat.
Roda pemulihan energi harus biasanya tidak digunakan dalam fasilitas multiproduct. Ketika roda tersebut digunakan mereka tidak seharusnya menjadi sumber kemungkinan kontaminasi (lihat Gambar 7). CATATAN: alternatif untuk roda energi-recovery, seperti cross over heat exchanger piring, dapat digunakan dalam fasilitas multi produk.
Potensi kebocoran udara antara udara pasokan dan pembuangan udara saat melewati roda harus dicegah. Tekanan relatif antara pasokan dan sistem pembuangan udara harus sedemikian rupa sehingga sistem pembuangan udara beroperasi pada tekanan rendah dari sistem pasokan.