Cleaning & disinfection in a Cleanroom
|
|
|
- Arthur Terry
- 7 years ago
- Views:
Transcription
1 1 Cleaning & disinfection in a Cleanroom June 2015 Michael Richter
2 2 Overview The need and consequences of using a disinfectant The cleaning and disinfection SOP
3 3 Why do we need a disinfectant? EFFICACY The consequences of using a disinfectant that you see everyday (free of charge!) are: Residues Corrosion Operator complaints Increased workload for QA department Each of these consequences reduces your profit
4 4 Residues You have two options: 1. You do NOT rinse 2. You rinse
5 5 1. No Rinsing A cosmetic issue EM results errors : sticky floor (more sticky than Petri Dish?) Disinfection variances? Cross contamination from lower to higher grade and chance it will contaminate a final manufactured batch
6 2. Rinsing 6 Manpower : how much does a person cost per hour : 50 80? Cost of the rinsing liquid : Alcohol : sterile or non sterile Water : sterile? - Origin of the H2O - How to transfer - H&S issue : slippery - Contamination risk - What to do with the waste water? Additional mopheads, new sterile buckets QA needs more SOP s Rinsing or Diluting? How is it validated : cost The more SOP s the more difficult questions from audits STOP production : cost 1 hour of production : to or more?...
7 7 Corrosion You have two options: 1. You do NOT rinse 2. You rinse
8 8 1. No rinsing You have the same issues as with the residues: Discoloration EM results? Particles release Cross Contamination Disinfection variances And You have extra cost of buying new SS materials.
9 9 2. Rinsing You have the same issues as with the Residue discussion Manpower Extra alcohol or extra water Extra mopheads and buckets Rinsing or Diluting QA SOP s and validation NO production
10 10 Operators Bad smell Irritation H & S issues CONSEQUENCES OF THIS : More protective garments Install special procedures People dislike the product : Dilution errors Frequence of sporicidal use decreases
11 11 Optimize QA work and SOPs Raw materials (concentrate) + water Quality of the water Dilution Cleanroom cost for the dilution Transfer into other cleanrooms. Packaging Sterilisation Certificate of analysis, sterility, stability Equipment ( filters, autoclave,...) Personnel Regulations Forecast and planning of production
12 12 Which disinfectants to chose? Your decision should be driven by a TCO review To improve performance To decrease production cost
13 13 Cleaning and disinfection procedures There are two types of surface: Small surfaces (critical surfaces) such as: production line LAF Isolator Door handles Gloves Large surfaces: Floors Walls Ceilings
14 14 Best Pratice : First Clean Then Disinfect Everyday? Depends on situation!!
15 15 Small surfaces procedure Ready to use product with limited rinsing: Monday Tuesday Wednesday Thursday Friday Product Alcohol Neutral Detergent Rinsing Product NO rinsing WFI H2O or high grade alcohol. If needed Sporocidial
16 16 Small surfaces procedure Ready to use product with limited rinsing: Alcohol: non corrosive + non irritant + no residues Neutral deteregent : non ionic non corrosive + non irritant + moderate residues Sporocidial H2O2 non corrosive + no residues
17 17 Large surfaces procedure Monday Tuesday Wednesday Thursday Friday Product Low residue broad spectrum disinfectant Neutral detergent Rinsing NO Daily Rinsing WFI H2O or high grade alcohol If needed Product Sporocidial
18 18 Large surfaces procedure Ready to use product with limited rinsing: Broad spectrum disinfectant Low QUAT, non corrosive, non irritating, minimal residues Neutral deteregent : non ionic non corrosive + non irritant + moderate residues Sporocidial H2O2 non corrosive + no residues Or Active Chlorine Need for a rinsing step
19 19 Back up / Shut down procedure Ready to use product, rinsing is recommended: Product Rinsing Product Rinsing Back up or after shut down Neutral Detergent WFI or high grade alcohol recommended Sporocidial WFI or high grade alcohol recommended Neutral detergent non ionic, non corrosive, non irritating, moderate residues Sporocidial Active Chlorine Need for a rinsing step
20 20 Added value services We have a team of validation experts which are available for supporting your Efficacy Validation testing SiteCheck support
21 Questions? 21
22 22 Cleaning & disinfection in a Cleanroom June 2015 Michael Richter
Cleaning. By the end of this chapter, you will be able to: Introduction. Definitions. Chapter 9
Chapter 9 By the end of this chapter, you will be able to: l Define the terms cleaning, decontamination, disinfection l List the factors that affect disinfection l Describe the aims of a cleaning schedule
Cleaning and Disinfection Agenda. 1. Cleanroom Classification. Cleanroom Classification. What does contamination mean? Types of contamination
Cleaning and Disinfection Agenda CLEANING AND DISINFECTION TECHNIQUES Barbara Wessels Key Account Manager Ecolab Contamination Control October 2014 1. Cleanroom classification and definition 2. Sources
Environmental Monitoring
Environmental Monitoring Purpose of Environmental Monitoring Critical process within the pharmaceutical and biotechnology industries. Determines the microbial and particulate content of cleanroom air and
The Perfect Partnership for GMP Cleaning Services. Total Cleaning Solutions from Micronclean & Isocleanse
The Perfect Partnership for GMP Cleaning Services Total Cleaning Solutions from Micronclean & Isocleanse 02 03 The Micronclean Offer Micronclean have offered a specialist ISO Class 4/GMP Grade B cleanroom
The use of risk assessment tools for microbiological assessment of cleanroom environments. by Tim Sandle
The use of risk assessment tools for microbiological assessment of cleanroom environments by Tim Sandle Email: tim.sandle@bpl.co.uk / timsandle@btinternet.com Web: www.pharmig.blogspot.com Environmental
DECEMBER 2015 PTAB Public Hearing Schedule
IPR 2015-00021 Tuesday, December 01, 2015 9:00 AM A ALEXANDRIA, VA 2013-003491 12422863 Tuesday, December 01, 2015 9:00 AM (MST) 14-133 DENVER, CO 2013-003763 11839384 Tuesday, December 01, 2015 9:00 AM
A GUIDE TO AVA FOOD FACTORY GRADING SYSTEM
A GUIDE TO AVA FOOD FACTORY GRADING SYSTEM Introduction The main objective of the Food Factory Grading System is to ensure that the food manufacturers observe good manufacturing practices so as to produce
ATS-SOI-5910 Page: 1 of 7. Approval Block. Prepared by: Signature Date. Evan Parnell 04 AUG 2014. Reviewed by: Signature Date. Brian Flynn 04 AUG 2014
ATS-SOI-5910 Page: 1 of 7 Approval Block Prepared by: Signature Date Evan Parnell 04 AUG 2014 Reviewed by: Signature Date Brian Flynn 04 AUG 2014 Approved by: Signature Date Kristal Jewell 04 AUG 2014
Name of Business. Record 1- Approved Food Suppliers List
Record 1- Approved Food Suppliers List Supplier No. Details of Supplier (Name, address, contact details) Product Description Approved Supplier Date approved Corrective Action Reject suppliers that do not
Selection of Disinfectants for Use in the Pharmaceutical Industry. Tim Sandle Head of Microbiology Bio Products Laboratory
Selection of Disinfectants for Use in the Pharmaceutical Industry Tim Sandle Head of Microbiology Bio Products Laboratory Introduction Cleaning and disinfection of surfaces are essential steps for maintaining
Managing Water Infiltration into Buildings. Water Damage Check List
Managing Water Infiltration into Buildings A Systematized Approach for Remediating Water Problems in Buildings due to Floods, Roof Leaks, Potable Water Leaks, Sewage Backup, Steam Leaks and Groundwater
Easy as 1-2-3 instructions on how to install or replace the Cleanviro waterless urinal tablet
Easy as 1-2-3 instructions on how to install or replace the Cleanviro waterless urinal tablet 1. FOR NEW INSTALLATION, TURN OFF THE MAIN WATER SUPPLY OF THE URINAL AND DRAIN THE WATER TANK BY FLUSHING
U11 Boys Black March 21st Monday 6:00-7:30 p.m. Damien Training Field 2 March 24th Thursday 4:30-6:00 p.m. Damien Training Field 2 March 28th Monday 6
U11 Boys Navy March 21st Monday 4:30-6:00 p.m. Damien Training Field 2 March 24th Thursday 6:00-7:30 p.m. Damien Training Field 2 March 28th Monday 4:30-6:00 p.m. Damien Training Field 2 March 31st Thursday
Cruise Line Agencies of Alaska. Cruise Ship Calendar for 2016 FOR PORT(S) = KTN AND SHIP(S) = ALL AND VOYAGES = ALL
Cruise Line Agencies of Alaska Cruise Ship Calendar for 2016 FOR PORT(S) = KTN AND SHIP(S) = ALL AND VOYAGES = ALL Page 1 of 5 Sunday, May 1 07:0-18:0 Monday, May 2 Tuesday, May 3 Wednesday, May 4 Thursday,
Cleaning Guidelines for Care Homes. Includes cleaning standards for the general environment and equipment
Cleaning Guidelines for Care Homes Includes cleaning standards for the general environment and equipment Contents Page 1. Background 2. Setting the Standard 3. Introduction to Cleaning 4. Cleaning 5. Disinfection
SOUTH CAROLINA. Downloaded January 2011
SOUTH CAROLINA Downloaded January 2011 1401. General (II) B. When meals are catered to a facility, such meals shall be obtained from a meal service establishment graded by the Department, pursuant to R.61
CLEAN UP FOR VOMITING & DIARRHEAL EVENT IN RETAIL FOOD FACILITIES
CLEAN UP FOR VOMITING & DIARRHEAL EVENT IN RETAIL FOOD FACILITIES GENERAL INFORMATION Noroviruses are a group of viruses that cause gastroenteritis [gas-trō-en-ter-ī-tis] in people. Gastroenteritis is
Cruise Line Agencies of Alaska. Cruise Ship Calendar for 2016 FOR PORT(S) = KTN AND SHIP(S) = ALL AND VOYAGES = ALL
Cruise Line Agencies of Alaska Cruise Ship Calendar for 06 FOR PORT(S) = KTN AND SHIP(S) = ALL AND VOYAGES = ALL 6: Friday, April 5, 06 Cruise Line Agencies of Alaska, Cruise Ship Calendar for 06 Page
Fixture List 2018 FIFA World Cup Preliminary Competition
Fixture List 2018 FIFA World Cup Preliminary Competition MATCHDAY 1 4-6 September 2016 4 September Sunday 18:00 Group C 4 September Sunday 20:45 Group C 4 September Sunday 20:45 Group C 4 September Sunday
ASTCCR2 - SQA Unit Code H548 04 Carry out and complete clean-room cleaning operations
Carry out and complete clean-room cleaning Overview 1 Carry out clean-room 2 Remove and store equipment, tools and materials after clean-room 3 Remove and dispose of contaminated material after clean-room
Sample Pharmacy CLEANING AND SANITIZING PROCEDURE P-304.1
P-304.1 1.0 Definition and Purpose: To standardize and define the process by which the controlled Cleanroom environments (ISO Class 5, 7, and 8) and the general pharmacy prep area is cleaned, disinfected,
Environmental Monitoring
Chapter 10 Environmental Monitoring By the end of this chapter, you will be able to: l List the types of environmental testing l Name three types of checks that are carried out to ensure the isolator is
Policies. Prep Room Policies
Introduction INTRODUCTION The Microbiology Prep Room is located in 531A Life Sciences Building. The telephone number is 372-8609. It is open from 7:30 a.m. to 4:30 p.m. during the fall and spring semesters.
BSL 1 Laboratory Biosafety Manual
BSL 1 Laboratory Biosafety Manual Version 1.0 Idaho State University, Office for Research Institutional Biosafety Committee (IBC) 1651 Alvin Ricken Drive, Pocatello, ID 83201-8046 Phone: 208-282-2179 Fax:
Part of The Revised Healthcare Cleaning Manual
Part of The Revised Healthcare Cleaning Manual CONTENTS Welcome Foreword 7.1.8 Specialised cleaning tasks a. Barrier-nursed rooms using a chlorine-based disinfectant cleaning product b. Terminal cleans
Beverage Industry Sanitation Program
Beverage Industry Sanitation Program Proper sanitation in food processing facilities is critical to ensure the production of wholesome, quality products for your customers and a safe environment for your
ACO Cleaning principles for drainage
Cleaning procedures ACO Cleaning principles for drainage Page Introduction 3 Principles of cleaning 4 Cleaning procedures ACO cleaning principles for drainage Cleaning chemicals 5 Manual cleaning of drainage
Aseptic preparations, including TPN, for a limited number of patients
Aseptic preparations, including TPN, for a limited number of patients Group F (TPN) 1 Objective Presentation of our business case: setting up an aseptic TPN production in the Hilton Pharmacy instead of
Checklist for a Physical Containment Level 2 (PC2) Laboratory Facility
Checklist for a Physical Containment Level 2 (PC2) Laboratory Facility (The Gene Technology Regulator s Guidelines for Certification of Facilities/Physical Containment Requirements applies) Facility Name:.
CHILDCARE SETTINGS. Childcare Settings
Childcare Settings This document provides guidelines and recommendations for cleaning childcare settings such as nurseries, crèches and schools in the event of a disease outbreak in the vicinity. Cleaning
CARE HOMES AND NURSING HOMES
Care Homes and Nursing Homes: This document provides guidelines and recommendations for cleaning care homes and nursing homes in the event of a disease outbreak in the vicinity. Cleaning and disinfection
Introducing an All New Line of Cleaning Chemicals
www.alltemp.ca Introducing an All New Line of Cleaning Chemicals Coil Cleaners & Brighteners Metal Cleaning Detergents Ice Machine Cleaners Scale Removers Electronic Cell Cleaner Degreasing Solvent Leak
DNA Analyst Training Laboratory Training Manual Protocol 2.02 Clean Technique
DNA Analyst Training Laboratory Training Manual Protocol 2.02 Clean Technique This laboratory protocol (or part thereof) has been provided as an example of a laboratory SOP, courtesy of the Illinois State
Facility Cleaning & Monitoring. Cleaning
Facility Cleaning & Monitoring Cleaning GTP Regulations: 21CFR Part 1271.190 Maintain facility in clean, sanitary & orderly manner Establish & maintain procedures for facility cleaning Assign responsibility
KitchenPro Cleaner Safer Healthier
Cleaner Safer Healthier The first challenge is to establish a clean and safe kitchen Key challenges: Maintain food safety Ensure employee safety Increase productivity Trips and slips caused by wet or slippery
Laboratory Biosafety Plan Template. For Biosafety Level 1 and 2
Laboratory Biosafety Plan Template For Biosafety Level 1 and 2 [Your Name] [Your Title] Winston-Salem State University [Building Name, Room Number] Winston-Salem, NC [Preparation Date] Table of Contents
Training on Standard Operating Procedures for Health Care Waste Management Swaziland 12 May, 2011
Training on Standard Operating Procedures for Health Care Waste Management Swaziland 12 May, 2011 Safe Infectious Waste Handling and Transport Objective Waste Overview Roles and Responsibilities of Waste
Understanding USP 797
DDK Scientific, Corp. Raul Duarte June 2008 Copyright DDK Scientific, Corp. 2008, 2009 DDK Scientific, Corp. Proprietary The purpose of USP 797 is to prevent harm and fatality to patients that could result
Detergents in CSSD. Wim Renders
Detergents in CSSD Wim Renders http://www.aqualitybv.eu Water is the solvent For pre-rinsing (cold): tap water In the ultra sonic cleaner: soft (preferably) or RO water; For manual cleaning: cold tap
Protection for hand eczema
Oxford University Hospitals NHS Trust Department of Dermatology Protection for hand eczema Information for patients What can I do to help my hand eczema? Hand eczema (the same as hand dermatitis) is normally
Design, Operation and Management of GTP/GMP Cell Engineering Facilities
Design, Operation and Management of GTP/GMP Cell Engineering Facilities Scott R. Burger, MD Advanced Cell & Gene Therapy BFDA 2007 International Symposium on Regulation of Human Cell and Tissue- Based
THE BLUE WASHING BOOK
Resources For other booklets and resources visit the Grampians Region Health Collaborative Website Infection Control at: http://www.grhc.org.au/infection-control A LITTLE YELLOW INFECTION CONTROL BOOK
Assembly and Cleaning. Prototype FDC Wire Boards
Assembly and Cleaning Prototype FDC Wire Boards Fernando J. Barbosa, Kim S. Shinault, Michelle Brisiel 23 January 2009 1. Introduction Particle detectors employ printed circuit boards (PCB) to assemble
A Guideline for Cleaning Up After Flood or Sewer Back-up
A Guideline for Cleaning Up After Flood or Sewer Back-up Revised 2010-03 INDEX PAGE Index 2 Personal Protection 3 Procedure for Cleaning Up 3 Safety 4 Initial Clean-up 5 Clean-up and Disinfection 5 Disinfectants
Biological Safety Program
Risk Management & Safety Main Office, Wyoming Hall Phone: (307) 766-3277 Fax: (307)766-6116 Regulated Materials Management Center Phone: (307)766-3696 Fax: (307)766-3699 Web: www.uwyo.edu/ehs Email: UWEHS@uwyo.edu
Cruise Line Agencies of Alaska. Cruise Ship Calendar for 2012 FOR PORT(S) = KTN AND SHIP(S) = ALL AND VOYAGES = ALL
Cruise Line Agencies of Alaska Cruise Ship Calendar for 0 FOR PORT(S) = KTN AND SHIP(S) = ALL AND VOYAGES = ALL :8 Tuesday, January 0, 0 Cruise Line Agencies of Alaska, Cruise Ship Calendar for 0 Page
Bench Autoclave. Standard Operating Procedure. For Installation, Use and Maintenance
Bench Autoclave Standard Operating Procedure For Installation, Use and Maintenance 1. Introduction This SOP is intended for use with the following model, in a laboratory context: Type: Nuve Bench Top Steam
b. Alkalinity make your life easier and get the alkalinity between 80 and 120 PPM. c. ph from 7.2 and 7.8 so that the other chemicals work properly
1. Adding Chemicals to your water: Chemicals should be added slowly over a period of time. Pool owner/operators need to remember that all chemicals added will have an effect beyond their intended purpose.
Biosafety Spill Response Guide
Yale University Office of Environmental Health & Safety Biosafety Spill Response Guide Office of Environmental Health & Safety 135 College Street, 1 st Floor, New Haven, CT 06510 Telephone: 203-785-3550
1 The quality management system (QMS) is the corner stone of compliance to GMP. The QMS is made up of several documents, that when followed ensures the GMP compliance of the process, facility and company.
Cruise Line Agencies of Alaska. Cruise Ship Calendar for 2013 FOR PORT(S) = KTN AND SHIP(S) = ALL AND VOYAGES = ALL
Cruise Line Agencies of Alaska Cruise Ship Calendar for 0 FOR PORT(S) = KTN AND SHIP(S) = ALL AND VOYAGES = ALL 9:5 Friday, January 0, 0 Cruise Line Agencies of Alaska, Cruise Ship Calendar for 0 Page
Environmental Monitoring of Clean Rooms
Environmental Monitoring of Raul Duarte President DDK Scientific, Corp. Copyright DDK Scientific, Corp. 2008, 2009, DDK Scientific, Corp. Proprietary A manufacturing facility for pharmaceutical products
Page 1 of 2. Dear Occupant:
Page 1 of 2 Dear Occupant: You contacted the City of Lincoln Park to claim that you discovered that you had suffered property damage or personal injury as a result of a sewage disposal system event. Enclosed,
FEBRUARY 2016 PTAB Public Hearing Schedule
2013-004485 11629982 Tuesday, February 02, 2016 9:00 AM (EST) B ALEXANDRIA, VA 2013-004694 12520565 Tuesday, February 02, 2016 9:00 AM (EST) B ALEXANDRIA, VA 2013-005264 13196232 Tuesday, February 02,
Bed Cleaning Procedure
This is an official Northern Trust policy and should not be edited in any way Bed Cleaning Procedure Reference Number: NHSCT/10/308 Target audience: Nursing and Midwifery Staff Sources of advice in relation
OCCUPATIONAL SAFETY AND ENVIRONMENTAL HEALTH GUIDELINE
OSEH Occupational Safety & Environmental Health OCCUPATIONAL SAFETY AND ENVIRONMENTAL HEALTH GUIDELINE Subject: Biohazardous (Medical) Waste Disposal Date: 08/19/09 Revision: 03 Page: 1 of 7 TABLE OF Section
Environmental Management of Staph and MRSA in Community Settings July 2008
Page 1 of 7 Environmental Management of Staph and MRSA in Community Settings July 2008 Questions addressed on this page What are Staph and MRSA? How is Staph and MRSA spread? What is the role of the environment
SAFE HEALTHY CHILDREN A Health and Safety Manual for Childcare Providers
TABLE OF CONTENTS Chapter 7: Food Storage and Preparation Safe Food: Food Storage and Preparation 7.1 Requirements of the Day Nurseries Act... 7.2 Recommendations of the Medical Officer of Health... 7.2
CLEAN ROOM MONITORING REGULATORY STANDARDS
CLEAN ROOM MONITORING REGULATORY STANDARDS Air Classification as per Schedule M Maximum permitted number of particles / m3 equal or above at rest in operation 0.5µm 5.0µm 0.5µm 5.0µm A 3,520 29 3,500 29
#9. EFFECTIVE CLEANING, MAINTENANCE, AND PEST CONTROL PROGRAMS FOR YOUR HACCP PLAN
#9. EFFECTIVE CLEANING, MAINTENANCE, AND PEST CONTROL PROGRAMS FOR YOUR HACCP PLAN by O. Peter Snyder, Jr., Ph.D. Hospitality Institute of Technology and Management In past articles, I have discussed supplier
Business Administration Certificates
T1 Important Dates Semester 1 T9a Business Administration Certificates Faculty of Business and Information Technology Timetable 2014 Orientation: 14 February Start Date: 17 February End Date: 27 June Semester
FDA and the Compounding Pharmacy
FDA and the Compounding Pharmacy Scott Sutton, Ph.D. scott.sutton@microbiol.org 41 Overview of Presentation The Recent Events GCP and GMP Basics the 483 Review H.R. 3204 Outsourcing Facility Preparation
OVERVIEW OF CONSULTING AND AUDITING PROJECTS
OVERVIEW OF CONSULTING AND AUDITING PROJECTS AEROSPACE & AUTOMOTIVE Aircraft Propellers - The buildup of static electricity on propeller blades was a concern. SOLUTION: Materials were tested at ETS and
ISO 14001-2004 AUDIT CHECKLIST
-2004 AUDIT HEKLIST REQUIREMET Environmental aspects What evidence exists that the organization has established, implemented and maintains (a) procedure(s) to identify the environmental aspects of its
Arizona State University Institutional Animal Care and Use Committee STANDARD INSTITUTIONAL GUIDELINE RODENT SURGERY
Arizona State University Institutional Animal Care and Use Committee STANDARD INSTITUTIONAL GUIDELINE RODENT SURGERY It is the policy of the IACUC that all survival surgeries involving rodents be conducted
Risk-Based Environmental Monitoring. Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI
Risk-Based Environmental Monitoring Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI Presenter Marsha Stabler Hardiman Over 20 years experience in the
Food Safety Guide for Family Day Care Educators
Food Safety Guide for Family Day Care Educators Department of Health and Human Services About this Guide This Guide is designed to help Family Day Care (FDC) Educators make safe and healthy meals for the
Cleaning validation of cleanrooms and preparation equipments
Cleaning validation of cleanrooms and preparation equipments Head of production Central Pharmacy, Geneva University Hospitals EAHP Foundation Seminar: Patient Safety; More About Compounding" 23-25 May,
A Basic Introduction to Clean Rooms
A Basic Introduction to Clean Rooms A cleanroom is a controlled environment where products are manufactured. It is a room in which the concentration of airborne particles is controlled to specified limits.
Professional Certification in Biological Waste Management Examination Content, Sample Questions & References
Professional Certification in Biological Waste Management Examination Content, Sample Questions & References The IFBA s Professional Certification (PC) in Biological Waste Management identifies individuals
HACCP and ISO 22000 food safety management synergies with Environmental Management System
HACCP and ISO 22000 food safety management synergies with Environmental Management System Horizon 2020 Clean Technologies: Application to the food processing industry 2012 04 25 Agenda 2 Food safety standard
Protocol for Disinfection of Cell Culture and Tissue Culture in Media:
Protocol for Disinfection of Cell Culture and Tissue Culture in Media: Location: Hickory Hall 001 Director: Dr. Guido Verbeck DECONTAMINATION OF CELL CULTURE WASTE Cell culture has become a common laboratory
Qualification of Cleanrooms and Environmental Monitoring - Practical Approaches in Europe
Qualification of Cleanrooms and Environmental Monitoring - Practical Approaches in Europe 1 Dr. Doris Herrmann Zum Eselsbachtal 20 67657 Kaiserslautern Doris.Herrmann@GMP-unlimited.de www.gmp-unlimited.com
Basic Requirements For Aseptic Manufacturing Of Sterile Medicinal Products A Comparison Between Europe And USA
Basic Requirements For Aseptic Manufacturing Of Sterile Medicinal Products A Comparison Between Europe And USA Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs
Stenner Pump Chlorinator Installation & Start Up Guide
Clean Water Made Easy www.cleanwaterstore.com Stenner Pump Chlorinator Installation & Start Up Guide Thank you for purchasing a Clean Water System! With proper installation and a little routine maintenance
MAINTAINING YOUR SPA WATER
MAINTAINING YOUR SPA WATER Tap water that is safe to drink is not always safe for a spa. Normal tap water is usually filled with minerals and microcontaminants that are not visible to the naked eye. Properly
RELEVANT HACCP CHARTS: Preparation, Service
HOUSE RULES PERSONAL HYGIENE 4.8 RELEVANT HACCP CHARTS: Preparation, Service PERSONAL HYGIENE HOUSE RULES Why is personal hygiene important? People working in your business can contaminate food or spread
Disinfect Reusable Supplies and Equipment
Section 5 Disinfect Reusable Supplies and Equipment This section describes how to: Prepare disinfectants. Clean and disinfect used gloves before reuse. Clean and disinfect used medical instruments and
THE UNIVERSITY OF NEWCASTLE- SCHOOL of BIOMEDICAL SCIENCES
Page: 1 of 7 1. Purpose: 1.1. To describe the procedures to be used when dealing with chemical or microbiological spills. 2. Equipment: 2.1. Spill Kit 2.2. Miscellaneous items as listed 3. Materials: 3.1.
PACUC Guidelines. Rodent Survival Surgery
PACUC Guidelines Rodent Survival Surgery Guidelines for rodent survival surgery are based on the National Research Council Guide for the Care and Use of Laboratory Animals 8 th edition and the Animal Welfare
Effective Cleaning and Sanitizing Procedures
JIFSAN Good Aquacultural Practices Program Effective Cleaning and Sanitizing Procedures By Alan Parker JIFSAN Good Aquacultural Practices Manual Section 9 Effective Cleaning and Sanitizing Procedures Why
Clean Start. Basic Skills ESOLWorkbook Entry Two
Clean Start Basic Skills ESOLWorkbook Entry Two Index P1 Introduction P19 Task 7 Criteria Rt/E2.3 P2 Initial Assessment P20 Task 8 Criteria Rw/E2.3, E2.4 P5 Task 1 Criteria Rw/E2.1, Wt/E2.1, Ww/E2.1 P21
FMI Listeria Action Plan for Retail Delis
FMI Listeria Action Plan for Retail Delis November 2012 Listeria control at retail is an ongoing challenge. FMI and our members are committed to finding ways to control the growth and if possible, eliminate
STANDARD OPERATING PROCEDURES SPILL RESPONSE AND CLEAN-UP OUTSIDE BIOSAFETY CABINET
BIOLOGICAL SPILL KIT IN A 5 GALLON BUCKET WITH LID Spill response and cleanup procedures (SOP) 1 Notepad 1 Pen 6 Business cards 1 Permanent marker 1 trash bag 6 Biohazard stickers 1 roll duct tape 1 roll
Cleaning up after sewage backup
Be prepared Being prepared before an emergency strikes will benefit you greatly in: Reducing your stress and protecting your health. Minimizing possible exposure to health hazards. Minimizing loss to personal
Requirements for Special Event Food Vendors
Niagara Region PUBLIC HEALTH Requirements for Special Event Food Vendors Please be advised that it is the responsibility of each Special Event Food Vendor to be aware of and in full compliance with the
Achievement Test Administration Schedule: January 2016
Achievement Test Administration Schedule: January 2016 Note: Achievement tests must be administered according to the dates and times indicated in this schedule, unless an alternate schedule has been approved
Cleanroom. For. Sterile Manufacturing Facilities
Cleanroom For Sterile Manufacturing Facilities Praphon Angtrakool Food and Drug Administration 1 WHO TRS No. 823 Annex 1, 1992 (1) General 17.1 The production of sterile preparations should be carried
Biosafety Level 2 (BSL-2) Safety Guidelines
BLS-4 Biosafety Level 2 (BSL-2) Safety Guidelines BSL-3 BSL-2 BSL-1 BSL-2 builds upon BSL-1. If you work in a lab that is designated a BSL-2, the microbes used pose moderate hazards to laboratory staff
OESO Ergonomics Division...919-668-ERGO(3746) Duke Police...919-684-2444 Corporate Risk Management... 919-684-6226
Musculoskeletal Disorders (MSDs) Develop over time and can take a long time to heal Can be quite painful and reduce overall effectiveness and efficiency Occur in any part of the body A variety of risk
Campus Services Hints and tips for residents
Campus Services Hints and tips for residents We have compiled this webpage to help University residents with simple tips and hints about cleaning kitchen areas - which are residents responsibility. We
Oxivir Tb and Accelerated Hydrogen Peroxide (AHP) Frequently Asked Questions
Oxivir Tb and Accelerated Hydrogen Peroxide (AHP) Frequently Asked Questions What is Accelerated Hydrogen Peroxide (AHP)? AHP is a patented synergistic blend of commonly used, safe ingredients that when
CLEANING AND SANITIZING
CLEANING AND SANITIZING Cleaning and sanitizing procedures must be part of the standard operating procedures that make up your food safety program. Improperly cleaned and sanitized surfaces allow harmful
Middle & High School Planning
Middle & High School Planning from 6 th Grade 7 th Grade 8 th Grade Notes 2105 www.homeschoolcreations.net Freshman Sophmore Junior Senior High School Outline & Requirements Credits needed for graduation:
An Informational Pamphlet. 416 South East Street Lebanon, OH 45036
An Informational Pamphlet 416 South East Street Lebanon, OH 45036 What is Mold? Mold is a type of fungus that is present in our natural environment. Mold spores, which are tiny microscopic seeds, can
Taking care of your pool Water treatments A clean and safe pool, all year round.
Taking care of your pool Water treatments A clean and safe pool, all year round. Start-up, 5-step maintenance, winterizing and common problems. All the solutions: DISINFECTION, MULTIFUNCTION REGULATORS
Steps for Cleaning Mold
Michigan Department of Community Health Steps for Cleaning Mold Before getting started, get to know MOLD: Mend There are many places you can find mold in your home. However, mold always needs a damp or
Particle Counting and Environmental Monitoring In Pharmaceutical / Life Sciences
Particle Counting and Environmental Monitoring In Pharmaceutical / Life Sciences LIGHTHOUSE WORLDWIDE SOLUTIONS WWW.GOLIGHTHOUSE.COM Introduction The pharmaceutical and medical device industries are developing
Ebola Virus Disease: Waste Management Guidance. UNICEF Supply Division
Ebola Virus Disease: Waste Management Guidance 26 September 2014 0 Ebola Virus Disease (EVD): Waste Management Guidance In addition to the need to break the transmission of EVD between HCWs and their surrounding
Chapter 7 Equipment and Utensil Cleaning and Sanitization
Chapter 7 Equipment and Utensil Cleaning and Sanitization The importance of proper cleaning can be appreciated when one realizes that contaminated equipment (equipment and utensils which are not clean)