Cleanroom Clothing Survey

This questionnaire is designed to help Pharmig assess cleanroom clothing practices in the healthcare and pharmaceutical sector. The aim is to share best practices and issues. The results will be published in Pharmig News.

Personal details
Name Company (not mandatory) Date Sector (pharmaceutical or healthcare) Type of manufacturing conducted at your site Aseptic, non-sterile, cosmetic, powders, creams etc.

The survey is designed in different sections for different types of cleanroom clothing. Please complete whichever sections are relevant. Please provide as much information as you can. Part 1

Changing rooms for controlled environments

What types of cleanrooms or controlled environments are at your workplace? Controlled environment E.g. EU GMP graded, ISO, internal company standard

Is your controlled environment: aseptic operation, non-sterile manufacturing, other (please state) If so, please can you briefly summarise the differences.

Do your gowning standards differ for different cleanrooms?

Pharmig questionnaire #1

Pharmig Cleanroom Clothing Survey

Changing rooms for controlled environments

What is your procedure for staff entering changing rooms? Examples: Removing before entering the changing room: all make up such as lipstick, blusher, eye shadow, mascara, eye liner, powder, foundation and any other cosmetic that is applied onto the face and neck area.

What system is in place for the control of outdoor clothing and footwear? Do you classify your cleanrooms? If so, which standards do you follow? e.g., ISO, EU Annex 1, WHO etc. Please indicate if this is for both particulates and viable monitoring purposes What physical parameters apply to the changing rooms? (E.g. air-change rates, pressure differentials, HEPA filter grades etc.) Is there a limitation on the number of people allowed in a changing room? Where applicable, please add the source of the specification (e.g. ISO< EU GMP, FDA, WHO)

If so, what is the number per classification? Please can you explain how you arrived at this number? (e.g. review of environmental monitoring data)

If you have a maximum number of people allowed, did you qualify this? Do you perform environmental monitoring in your changing rooms?

Example: environmental monitoring study

Is this in the at rest or in operation? Please specify what type of monitoring do you perform (surface, active air), and frequency of monitoring. What is the frequency of monitoring?

Confidential

Page 2

2/24/2014

Pharmig Cleanroom Clothing Survey

Changing rooms for controlled environments

What is the cleaning and disinfection regime in place for your cleanroom? Please specify: a) Detergent type b) Disinfectant types c) Frequency of cleaning and disinfection d) Frequency of disinfectant rotation (if applicable)

Confidential

Page 3

2/24/2014

Pharmig Cleanroom Clothing Survey

Part 2

Cleanroom gowns
Do you use disposable gowns or are gowns laundered? If you use the disposable gowns are they worn more than once? Or are they discarded immediately after use? Is your decision regarding recycled or disposable suits based on cost or convenience, or another factor? How did you qualify your supplier of gowns (single use, and laundered) Recycled suits: Is there a maximum time that a suit can be laundered for? If you launder your gowns in house how did you qualify the washing process? Recycled suits: How is suit laundering tracked? Recycled suits: Do you have a gown repair policy? Recycled suits: Do you permit repairs to be made to suits? If so, how often and are there restrictions on the size of the tear? Example: bar codes This includes washing and irradiation cycles. Please indicate if you use a mix of disposable and laundered gowns.

Who conducts these repairs and how do you assess them? Disposable gowns: What materials are your gowns made from?

Confidential

Page 4

2/24/2014

Pharmig Cleanroom Clothing Survey

Cleanroom gowns
All suits: How long can a suit be worn for? i.e. how often must an operator change their gown? Do you have different standards for different cleanroom grades? All suits: If you have a maximum wearing time, how did you determine this? All suits: Do you have requirements for how suits are packaged? All suits: What are the most common complaints about your cleanroom suits? Have you experienced any issues with your gown suppliers? All suits: Have you audited your gown supplier? All suits: Are you concerned about static electricity? All suits: Are you concerned about chemical resistance? Example: environmental monitoring, particle counting, bacterial efficiency test.

Examples: vacuum packed, double bagged, folded so the legs of the suit do not strike the floor.

Examples: too hot, prone to tearing, shedding

If yes, please can you list some examples?

If yes, what is the frequency of audit?

If yes, how do you overcome this?

If yes, how have you determined the suit was acceptable?

Confidential

Page 5

2/24/2014

Pharmig Cleanroom Clothing Survey

Part 3

Gowning qualification and environmental monitoring

Example: observation, environmental monitoring How do you carry out staff gowning assessments? If you perform assessments, at what frequency are gowning assessments performed? Is there are requirement for staff entering clean areas to complete a health questionnaire? Are these periodic assessments at fixed time points or random assessments?

If so, how often is this completed?

Is the questionnaire reviewed by a health practitioner or by line managers? What type of health issues would exclude someone from working within a cleanroom?

Are cleanroom personnel monitoring (PM) plates taken as staff leave the changing room?

If yes, what is the frequency of monitoring? Are plates taken at different time points? Are plates only taken for certain cleanroom grades? (if so, which?) Which locations are selected? Are locations ever varied? Who takes the samples (e.g. self-monitoring or independent sampling)? What limits are applied to gown plates? Do you trend the data? If so, what measure do you use to assess a problematic trend?

Confidential

Page 6

2/24/2014

Pharmig Cleanroom Clothing Survey

Gowning qualification and environmental monitoring

Do you take personnel glove plates? If yes, what is the frequency? Are plates taken at different time points? Are plates only taken for certain cleanroom grades? (if so, which?) Do you trend the data? If so, what measure do you use to assess a problematic trend?

Part 4

Cleanroom gloves
What types of materials are your gloves manufactured from? What sizes of gloves do you typically use? Have you evaluated hand sanitizer efficiency on bare hands and gloved hands? If so, have you found any differences? Have you approved your glove supplier? How was the supplier approved? What Length of Glove do you use? Do you use Medical or Cleanroom gloves? Are they Hand Specific/Ambidextrous? Do you double glove? Do you use different colour gloves? Examples: latex, nitrile

Part 5

Confidential

Page 7

2/24/2014

Pharmig Cleanroom Clothing Survey

Cleanroom masks
What types of masks do you use? Do you source masks with certain bacterial filter efficiency? Is the masks tie or ear looped? Is the inside of the mask Hydrophilic?

Part 6

Cleanroom eyewear
Do you use safety glasses or goggles? Has there been a regulatory shift towards the use of fully enclosed goggles? If you use goggles, are these vented? How do you sanitise them/sterilise eyewear? How often is the eyewear replaced? Comments: (please add any further information)

Confidential

Page 8

2/24/2014

Pharmig Cleanroom Clothing Survey

Thank you for completing this survey. Tim Sandle & Rachel Blount, on behalf of the Pharmig committee. Please email your completed surveys to: info@pharmig.org.uk or post to: Pharmig Office T5 The Maltings, Roydon Road Stanstead Abbotts Hertfordshire SG12 8HG UK

Confidential

Page 9

2/24/2014