Questionnaire for quotation request Cleanroom Date : Prepared by : Client : Project : Location of work : Attendee(s) : Position(s) : Telephone : Email : 1. Work activities in the relevant cleanroom: 2. for PP4CE: Client’s question 3. Description of situation with measurements, if possible: Is a draft design of the cleanroom available? Yes / No If no, what are the required dimensions (L x W x H) and layout of the cleanroom areas? Area no. Length Width Height Kind of activity 4. What are the possible requirements that may be expected in the future: Area no. ISO GMP class Temperature RV [%] Air change Pressure Lighting [lux] 14644 [°C] per hour [Pa] % +/- % …. ºC +/- …. ºC …. …. ºC +/- ºC % +/- % …. …. …. …. ºC +/- ºC % +/- % …. …. …. …. ºC +/- ºC % +/- % …. …. …. …. ºC +/- ºC % +/- % …. …. …. …. (ISO class conform NEN-EN-ISO 14644-1:2016 / GMP class conform Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products 2008)
Questionnaire for quotation request Cleanroom Date : Prepared by : Client : Project : Location of work : Attendee(s) : Position(s) : Telephone : Email : 1. Work activities in the relevant cleanroom: 2. Client’s question for PP4CE: 3. Description of situation with measurements, if possible: Is a draft design of the cleanroom available? Yes / No If no, what are the required dimensions (L x W x H) and layout of the cleanroom areas? Area no. Length Width Height Kind of activity 4. What are the possible requirements that may be expected in the future: Area no. ISO 14644 GMP class Temperature [°C] RV [%] Air change per hour Pressure [Pa] Lighting [lux] …. ºC +/- …. ºC …. % +/- …. % …. ºC +/- …. ºC …. % +/- …. % …. ºC +/- …. ºC …. % +/- …. % …. ºC +/- …. ºC …. % +/- …. % …. ºC +/- …. ºC …. % +/- …. % (ISO class conform NEN-EN-ISO 14644-1:2016 / GMP class conform Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products 2008)
EN_Offerte-aanvraagformulier-PP4CE.docx