Cleanroom forum

Latest posts

• Which cleaning agent can be used to remove blood splashes or dried blood from a CG distributor without damaging it?
• Are there also WC facilities for the cleanroom area so that employees do not have to leave the cleanroom when they need to go to the WC?
• We are looking for films as packaging material for our large cleanroom appliances. What should we look out for when selecting films? What should we generally look out for in cleanroom packaging? Are there any standards?
• How long is the lead time in a mini environment until sterile air circulation is achieved and the laminar can be used?
• Can a local cleanroom class A according to EU GMP be achieved with a TISCH-LF 50?
• We would like to sell used cleanroom equipment. Where can we do this?
• How much does a Minienvironment cost?
• Is there a PE foam that is suitable for cleanrooms?
• Is it necessary to wear the face mask over the mouth AND nose in a "SMIF FAB" with ISO 6? Or is it sufficient if the face mask only covers the mouth and the nose can remain free? The product itself is protected in so-called SMIF pods.
• What is the quality of air that is blown from an ISO 7 zone through an ISO 35H HEPA filter? Is this air suitable for ISO 5?
• Could you please tell me if there is a standard as to how large the opening in a machine must be in order to carry out particle measurements.
• Is there an overview of cleanroom-compatible materials (equipment, ceiling/wall, floor, etc.) that takes into account the different requirements for cleanliness classes A, B, C and D?
• Are stoma wearers allowed to work in a cleanroom (here: ISO class 8, cleanroom class D)?
• Does it comply with the regulations to feed material directly from CNC to C?
• Does it make sense to position sensors for room technology and monitoring in the clean room in the same place?
• I have an enclosed filling line with different sectors that have different purity classes. The sectors have air short circuits due to their design. The conveyor belt passes through. How is the clean room to be assessed technically? Does the 10Pa pressure difference requirement between the classes/sections also apply here? Very bad: in the last section there must also be negative pressure so that the active ingredient is not inhaled by the personnel. ..
• Is it possible to convert a normal room into a clean room, is there such a thing as wall paneling and how much would a 100m² room cost?
• According to ISO-14644, leakage tests must be carried out on the terminal HEPA filters. What is the situation if only EPA filters (H11) have been installed in cleanrooms (RRK D)? Is a classification measurement of the cleanroom sufficient in this case, as H11 filters cannot be tested in accordance with ISO 14644-3?
• We have recently opened a cleanroom (class 8) and are now considering having it certified. My question is whether this certification can only be carried out by a dAKKS accredited laboratory. We are currently working with a non-accredited laboratory. Would such a certification be permissible?
• Is there a requirement that the flow velocity and the cleanliness class in a hot air tunnel must be verified under operating conditions (approx. 300°C) or is this technically feasible/sensible?
• In future, male employees in our company will have to wear a beard protector (cleanroom class 8). Is there a statement on how many mm or more this must be worn?
• Can I enter a cleanroom C from a CNC area? Where are there specific guidelines on this?
• Our notified body has asked us to install warning and action limits with regard to microbiology. Where are these limits usually located in an ISO class 8 cleanroom (in operation)?
• What pressure do I need to operate an F9 filter properly?
• Are there any requirements from a standard that prevent the use/installation of a washbasin in the cleanroom? So far it is in the personnel airlock. We voluntarily comply with ISO 7. What risks are associated with this?
• Can the ISO-14644-1 standard also be used to classify the purity of dry, compressed ultra-pure air (CDA) or must the ISO-8573 standard be used?
• Which guideline is used to define an airborne germ measurement on the filter in CSSDs and cytostatics?
• How is the air exchange rate according to GMP to be interpreted? Does this mean the fresh air exchange rate or can the supply air from recirculation units with integrated filtration also be used to calculate the air exchange rate?
• Is it permitted to bring in people and required material via an airlock, or is it absolutely necessary to have an extra material airlock? This is an ISO 8 cleanroom, thank you for your help!
• Is it possible to operate an autoclave with demineralized water connection and drain in a GMP class B cleanroom? Or alternatively a 40 l table-top unit with 2 liter fresh and 2 liter waste water tank?
• How can cleanroom class 9 be ensured for a production area?
• We have a class D cleanroom and a class C clean bench in it. Our material is cleaned when it is introduced into the class D cleanroom. Does it have to be cleaned again when it is introduced / processed in the clean bench? Is there a requirement according to GMP?
• How do you calculate the excess supply air or leakage air volume?
• Question 1: Is it necessary to carry out flow visualizations for sterile workbenches during periodic requalification (what interval) or is an initial flow visualization sufficient? Question 2: Is there a regulation that describes what height the front screen of the sterile workbench should be in the working position and must a new flow visualization be carried out if this position is changed?
• Is it sufficient for requalifications to carry out cleanroom classifications and filter integrity (sterile operation) once a year in accordance with the current ISO 14644 or do shorter intervals (e.g. in accordance with PIC/S PI 032-2) of 6 months apply?
• Do you have socket cubes to hang from a cleanroom ceiling?
• Is a particle measurement of the filling alone sufficient for a qualified condition or do attached personnel and material locks also have to be measured. These differ in the pressure for filling. In other words, due to the lower pressure in the personnel airlock, particles should not actually enter the filling area. If measurements are unavoidable, they have the same measurement criteria as the filling process. And last but not least, is there an expert in AUT where you can have your SOPs assessed for correctness with regard to ISO? I look forward to your feedback.
• We use sedimentation plates on a daily basis, these come in a multipack of 10 plates that are shrink-wrapped several times. If 2 sedimentation plates are removed for sampling on Mondays (i.e. all outer packaging must be opened) and then plates are not needed again until Tuesdays, what is the safest way to store the unsampled plates in the opened packaging (storage in class D)? Thank you!
• Is there personal respiratory protection equipment in cleanroom class B except for work at safety workbenches?
• Are there any recommendations (manufacturer, product) for printing on cleanroom paper? The printer is to be used in a non-cleanroom laboratory!
• Are there specifications for the zero filter measurement for particle counters?
• Are there specifications for GMP areas as to how many controllers must be installed for monitoring (T°, pressure, ... etc.) per m2 of room area?
• Does it make sense to position sensors for room technology and monitoring in the clean room in the same place?
• What regulations are there regarding smoking in connection with work in the cleanroom?
• Are there regulatory requirements for cleanroom classes A to D regarding the air exchange rates that must be achieved (FDA-certified production)? If so, in which regulation?
• From which filter class must a tightness test be carried out? In this case, we are talking about filters for exhaust air inlets
• Are you allowed to smoke during breaks if you work in cleanroom class 8?
• What are the requirements for using an existing vertical conveyor for pallets, which is currently used in the black area, in cleanroom class CNC?
• Hello, is a printer permitted in an RRK C and D (in an area where equipment etc. is located - i.e. not an extra logging room)? Regarding the health examination of employees who enter the Reinrau, is it sufficient for the proof of the examination to be filed by HR, for example, or should it also be documented on a controlled document that the examination has been carried out?
• What does "< 1 CFU" actually mean for the permitted bacterial count for surface swab samples in cleanroom class A? Why is "0 CFU" not used - does this have a statistical background? For example, if there are 10 plates, nine of which have 0 CFU and one 1 CFU, are the values to be regarded as "passed" as a whole?