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New Cleanroom Build
Many companies are building cleanrooms for product or marketing reasons. We can help you from the start of your project ensuring you have an effective cleanroom designed for current and future expectations right through to a fully established working cleanroom with the required controls, documentation and training in place.
- Cleanroom Design Advice
- Cleanroom Validation (At Built, At Rest, In Operation)
- Training
- Protocol, Report and Procedure Writing
- Establish an Effective Environmental Monitoring Program (See Microbiological Services Section)
Microbiological Services
- Did you review your Environmental Monitoring limits recently?
- How did you set your Environmental monitoring limits?
- Are you having issues with out of spec results?
- Are you having problems finding a root cause to an investigation?
- Did you perform a risk assessment of your cleanroom with regard to identifying the most critical areas for sampling?
- Are you performing the correct types of sampling?
- Are you oversampling areas?
- Are you interpreting your Environmental Monitoring results correctly?
When we talk about Cleanroom Environmental Monitoring this is not just monitoring for viable contamination, but also non viable monitoring (particulates). In order to establish an effective Cleanroom Environmental Monitoring plan we must take into account all process that could potentially contribute contamination to the cleanroom environment or product. This includes monitoring the cleanroom environment, compressed air and water. |
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- Establish an effective Environmental Monitoring Program, in line with relevant ISO 14698, FDA and IMB regulations, including effective monitoring of
- Viable Microorganisms
- Particulates
- Compressed Air
- Water
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- Perform risk assessments to identify the critical and non critical areas of risk to product
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- Perform problem solving and investigations on out of spec results or product contamination issues
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- Establish cleanroom policies and procedures
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- Review and set alert and action limits
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- Bioburden validation, monitoring and setting of limits
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- Endotoxin validation and monitoring
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In House Microbiological Services
For companies who do not have the microbiological expertise in house or who do not require a full time microbiologist in house, this service provides the expertise on a part time basis or as required.
Auditing Services
Perform Cleanroom / CGMP audits
Perform Quality System audits for ISO 9001 and ISO 13485
Perform Supplier Audits
Review audit findings
Provide audit support during a customer/regulatory body audit
Sterilisation Services
Project Management Services
Project Manage Change within Cleanrooms
Project Manage Training and Upskilling of Personnel
Project manage New Cleanroom Build
Training Programs
All training programmes are delivered through SQT. And are tailored to cater for company specific requirements.
https://www.sqt.ie/CourseDetail.aspx?ID=544&Course=Controlling+Contamination+within+the+Cleanroom
| Course |
Details |
| Controlling Contamination & GMP in the Cleanroom |
(Duration: 1 day, Availability: In house and public courses) |
| Gowning Assessment Training |
(Duration: 1 day, Availability: in house course) |
| Effective Cleaning of a Cleanroom |
(Duration: 1 day, Availability: In house and public courses) |
| Cleanroom Microbiology |
(Duration: 1 day, Availability: In house and public courses) |
| Good Documentation Practices |
(Duration: ½ day, Availability: In house and public courses) |
Training Assessment Puzzles
- Make your training more fun and see how effective your training was!
- Try out a tailor made quiz as a tool for assessing.
- Quiz assessments come in different formats and are tailor made to conform with your specific procedures and relevant regulations
- Crosswords
- Multiple Choice
- Written Answers
- Exercises in reviewing poor GDP
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