1. D

    ISO: 13485:2016 Sec. 7.5.2 (C) - Requirements for cleanliness of product or contamination control

    Hello All, So the new requirement in section 7.5.2(c) says that I should have requirements for cleanliness of product or contamination control if "product cannot be cleaned prior to sterilization or it's use, and cleanliness is of significance in use". Do my current requirements for product to...
  2. I

    Clean room recovery program

    Good day to all! I´m working in a program of actions to perform in case of excursions of particles and drops of differential pressure in a clean room, we are working in a system of continuous monitoring, where be registered particles in the different places, differential pressure and...
  3. N

    Generic Rework/Reprocessing Procedure

    I'm trying to write my rework and reprocessing procedure and want to see a couple good examples or some advice. I am hoping to create it all in one document. Contract filling of OTC pharmaceuticals. Level 8 cleanrooms.
  4. M

    Scarf in Clean Room instead of Hair cover?

    If a scarf is worn for religious reasons (all hair is covered), does that person also have to wear a hair cover in a ISO 7 (Class 10,000) Clean Room?
  5. M

    What are ISO 7 Clean Room Requirements

    What specific requirements are there for this level of clean room? I'm not talking about the obvious requirements like particle count, air changes, filters, gowning, etc. I mean - would perfume or make up be allowed? How about paper? I can't see how these could affect the particle count. Is...
  6. I

    Cleanroom Actions in case of Actions Limit Alarm

    Hi to all We are implementing a continouos monitoring system in our cleanroom, and we want to have a document with actions to perform in case the system get alert and action alarms, do you know if any regulation ask for this kind of actions?, what kind of actions do you recommend? Regards...
  7. WalkingCube

    How to bring Cardstock into Cleanroom Environments

    Hello everyone, I have a question concerning how to bring cardstock into cleanroom environments. We have a medical device that will be packaged using a mounting card. The mounting card has assorted hook-like features on which the product will be clipped on. While I'm familiar with...
  8. S

    Should the primary drug containers be molded in ISO Class 7 clean room?

    We are in discussion with a pharmaceutical manufacture for manufacture of plastic primary drug containers. The customer wants these plastic injection molded primary containers to be molded in ISO Class 7 area as the Class 7 clean rooms have lower particulates while we feel that ISO Class 8...
  9. S

    ISO 7 and 8 Clean Room Cleaning

    Hey everyone. I am looking for some guidance/help on cleaning of ISO 7 and 8 Clean Room. Particularly on schedules of cleaning and extent of cleaning. -How often should floors be mopped? -How often should ceilings and walls be wiped down? -What are the appropriate cleaning solutions for...
  10. S

    Cleanrooms - Particle Measuring - ISO 14644

    We have a controlled environment, not a classified clean room, however we have been doing environmental checks, ie. particular monitoring. I have determined that based on the room size that I need to do 25 locations and in the past have been collecting 5 readings per location. Is the number of...
  11. I

    Water in a gowning room

    Hi to all Do you know if is there any regultation about the water used to wash hands in a gowning rooms? Thanks in advance:bigwave:
  12. I

    Number of HEPA filter in a room

    Good day I need information, s there any regulation where be established the number of HEPA filter according to the ISO classification? Thanks in advance Sergio Ávila
  13. S

    New clean room change submission - FDA Requirements

    We are in the process of building a new cleanroom for one of our class II device and was eager to know what documents would we would need to submit to the FDA for this change? Any help in this matter would be appreciated.
  14. A

    Sterile Garbage Bag for Clean Room

    Hello everybody, We are currently trying to identify solutions for sterile garbage bags for our clean room (Grade B). For now we try to disinfect the bags before they get into the clean room, however this is not a very reliable method for reducing contamination. Does anyone have an idea...
  15. N

    ISO 14644-1 Clean Room Occupancy State Validation Requirements

    According to revised version of ISO 14644-1, there is a revised statement which is as follows: Occupancy state(s) The air cleanliness class by particle concentration of air in a cleanroom or clean zone shall be defined in one or more of three occupancy states, viz. “as-built,” “at-rest” or...
  16. Ajit Basrur

    Do you monitor both 0.5 and 5 micron in ISO Class 8 cleanrooms?

    I have a question on the nonviable particle monitoring for ISO Class 8 cleanrooms. The particle monitoring is done for both 0.5 and 5 microns but the new ISO 14644-1:2015 recommends using one channel, and heard that most companies are planning to monitor the cleanrooms at 0.5 microns only. I...
  17. S

    Looking for ISO Class 8 Cleanroom Cleaning Procedure example

    Can any one share the procedure of ISO Class 8 cleanroom cleaning ? Much appreciated.
  18. Ajit Basrur

    MS Excel to study Correlation between Humidity & Differential Pressure

    I need help with MS Excel spreadsheet to study a correlation between Humidity values and Differential Pressure in a cleanroom. In the attached Excel spreadsheet, I am interested to see if the Humidity in ambient manufacturing area (column D) and Humidity in cleanroom (column K) had any...
  19. C

    Software for trending and reporting particulate testing

    What type of software is everyone using to track, trend and report particulate results in their clean rooms? I've been looking around and am not finding much, but I may not be looking in the right places.
  20. S

    What is the minimum pressure differential required for ISO Class 8 Clean Room?

    I would like to know what is the minimum pressure differential required for ISO Class 8 clean room ? I am asking this question because one of our clean room has a pressure differential of 0.02 inches water (clean room to gowning) and 0.01 inches water (gowning to outside). I feel this is too...
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