PARTICULATE. Massachusetts. We are pleased to announce that we have expanded to THE. Our Services Testing & Certification

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1 S U M M E R , V O L U M E 3. THE PARTICULATE I N S I D E T H I S I S S U E : MCI ACHIEVEMENTS 1 We are pleased to announce that we have expanded to Massachusetts MEET & GREET 2 Demand for quality service is an now taking that vast level of office is supported by a solidly ARE YOU PREPARED 2 opportunity for Micro-Clean (MCI) to expand our operations. For experience of our staff, and the high level of quality service established operations support team and headquarters facility TOO LITTLE, TOO LATE 3 more than 30 years MCI has been servicing the Mid-Atlantic territory with high quality testing, currently enjoyed by our local regional customers, to the New England market. In our recent located in Bethlehem, PA. Should a customer have an emergency arise or need to reduce GREEN TECHNOLOGIES 4 v a l i d a t i o n, c a l i b r a t i o n, certification and cleanroom survey of opportunities in the region, we have found that there down-time dramatically, the technical staff, parts and EM MONITORING 5 products. Working with clients in a highly regulated industry has is a need for a high quality service provider with the capability equipment available from the home office location, will ensure QUALITY TRAINING INDUSTRY NEWS LETTER FROM THE PRESIDENT Our Services Testing & Certification Laboratory Ventilation Management created the opportunity for us to develop the ultimate testing and reporting package. Our regional office expansion into Maryland, approximately 10 years ago, has provided us with the opportunity to fine tune our operations in our satellite office locations. This experience has allowed us to provide a seamless operation. of delivering a combination of multiple services performed in laboratories and controlled e n v i r o n m e n t v a l i d a t i o n, calibration and certification. To demonstrate our commitment to the current and future New England customers of MCI, we have established a regional office in Westborough, Massachusetts. Beginning in 2012, this local the client s needs are met. We at MCI look forward to the many opportunities that will confirm our commitment and allow us to provide our high quality level of testing, calibration and certification services to the New England territory. We have a service staff of 50 technicians that can be dispatched. No job is ever too big for us. Our services Space/Service Decontaminations MCI has many years of technical experience working with clients in office is fully staffed to provide the same quality services have been used exclusively by Schering/Merck, Wyeth and Pfizer Qualification Services the Pharma, Biotech, Clinical and delivered from our headquarters and have for four decades and Facility Systems Research industries. We are in Pennsylvania. The regional now you can too! Validation Equipment Validation Laboratory Calibration Field Calibration Energy and Efficiency Consultation Our sister Company Cleanroom Filters & Supplies -visit us at- Our newest facility is located in Westborough, Massachusetts. PHONE

2 S U M M E R , V O L U M E 3 Page 2 New England Meet & Greet On April 19, 2012, Micro-Clean, Inc. introduced our company at our Meet & Greet in Cambridge, Massachusetts. This proved to be an excellent opportunity for us to meet many new people in the New England area. The attendees at the Meet & Greet were able to view all the services that we offer in a comfortable environment. We had twelve table top displays which included colleagues from other local vendors. Our Technical Sales Consultants, Department Managers and John Wagner, CEO were available to answer any questions. At our corporate headquarters located in Pennsylvania we offer training classes and seminars presented by qualified professionals. We are planning on providing these seminars in the New England area in the near future. If you are interested in attending our classes please contact the office to be added to our mailing list. Contact Debbie Laubach for future classes and seminars. Phone Are you prepared for Regulatory Agency Inspections? Have you ever stopped to think if your facility s environment is in compliance? Has your facility had a significant deviation from the path of regulation? Any of the following examples of investigated observation can lead to an FDA 483 notice: We are here to help. Micro-Clean can help with a full range of services to enable your facility to meet the challenge of consistent compliance and achieve an effective Environmental Monitoring Program. Our services include: Failure to follow appropriate written procedures to prevent microbiological contamination of drug products to be sterile. [21 CFR (b)] Failure to establish and maintain procedures to control environmental conditions as required by 21 CFR (c). Control systems for monitoring environmental conditions during aseptic processing operations are inadequate [21 CFR (c) (10) (iv)]. Your firm does not have an adequate system for monitoring environmental conditions in aseptic processing areas [21 CFR (c) (10) (iv)]. Non-Viable particle counts, Air Viable and Surface Viable Sampling Cleanroom Validations Personnel Training - Gowning and cgmp Sampling Plan / Program Development Support compendial microbiological testing WHY Micro-Clean? We are your one stop shop from materials to sampling to the final report.

3 S U M M E R , V O L U M E 3 Page 3 Too Little, Too Late... Question: When should you notify Micro-Clean, Inc., that you are making changes to your existing cleanroom or building a new cleanroom? HEPA filter certification is a key part of a validation package. Some of the key elements for certification are Airflow Velocity and Uniformity, Air Changes per Hour, Room Differential Pressure, Filter Integrity Leak Testing and Particulate Testing. If any of the aforementioned items are outside the specifications, the room will not pass certification, and ultimately, validation of the room will fail. Due to the advances in technology and the ever-changing specification within the certification industry, it is becoming difficult for cleanroom designers to keep current with them all. As we all know, the cost of building a cleanroom is very expensive. Taking shortcuts or looking for the cheapest builder is not always the best option. There are many choices to be made when building a new cleanroom in regards to meeting required specifications. Do you need to meet the Federal Standard 209E (sunset in 1999), ISO or the EudraLex Volume 4? These are only some of the questions that need to be answered prior to starting the design phase of the project. Another important decision to be made involves the type of filter to be installed. Do you require a HEPA filter or an ULPA filter, or does the filter need to meet the EN 1822 requirements? Micro-Clean, Inc., is structured to allow its employees to stay on top of all of the changes within the industry. We have active members participate in the organizations that write the standards. We are one of the first individuals to know about the changes prior to them taking place due to our involvement within these organizations. Through our extensive internal training programs at Micro-Clean, Inc., we pass the information along to all of our employees so they will have first hand knowledge of the changes when working with our customers. This is accomplished by mandatory technical training sessions scheduled throughout the year. Each technician must complete and pass a written examination at the beginning of each training session. Answer: As soon as you know you are making a change or starting the building process, it is beneficial to notify us. This will allow Micro-Clean, Inc., to aid in the design consultation and product selection phase of the build. Through advise and consultation on items including: which filters to purchase, where to place the filters within the ceiling, where to place your production equipment, and how to eliminate potential problems, i.e. Lack of unidirectional airflow within your ISO 5 (class 100) room prior to it being built, Micro-Clean, Inc., can save you time and money. Thus, it is better to address changes, sooner than later and by having the involvement from Micro-Clean, Inc., at the beginning of your project; therefore, you will not end up saying I did Too Little, Too Late. Account Managers and Technical Staff of Micro-Clean

4 Micro-Clean Green Technologies, Inc. Page 4 Micro-Clean Green Technologies has recently introduced its LumaGuard Surface Protection for both interiors and exteriors of buildings and vehicles in the health care, pharmaceutical, biotech, food processing, hospitality and commercial sectors. INTERIORS become self-sanitizing and antimicrobial. Our Smart and Green photocatalytic oxidation (PCO) coatings transform all substrates, including walls, ceilings, equipment, furniture and fabrics into super-hygienic surfaces that destroy all contaminants such as : MRSA (bacteria) C. Diff (spores) Aspergillus (mold) And also odors and VOCs EXTERIORS become self-cleaning and reduce pollution. Surfaces treated with our LumaGuard service decompose all organic pollutants from industrial and automotive emissions, preventing the streaking commonly found on masonry, metal, vinyl, glass and other substrates. Mold and mildew will not grow on the PCO coated surfaces and UV degradation and fading are prevented. Exteriors also become super-hydrophilic, allowing rain, condensation or a simple water wash to sheet away any contaminants. Visible light energy is all that s needed to activate the titanium dioxide in Micro-Clean Green s photocatalytic nano-coating. Light excites the electrons in TiO2, producing oxidizers that are twice as strong as chlorine. Other natural ingredients, zinc and silicon dioxide are all combined in a water-based colloidal solution to provide an incredibly durable treatment that is effective for years. Our LumaGuard service uses specialized electrostatic spray equipment to produce an extremely strong negative charge that is attracted to the positive charge of the surface being coated. By virtue of the fine, atomized spray, the water base quickly evaporates, leaving only the thin, durable coating of nanoparticles, which bind to the surface of the molecular level. Continuously working, smart and innovative, Micro-Clean Green s photocatalytic coatings use the synergistic power of advanced nanotechnology and microbiology to ensure a safe and healthy world through green chemistry. LumaGuard has multiple interior uses from hospital rooms to biopharma clean rooms, as well as exterior building applications. Shown above on the left, are two examples of exterior application before and after.

5 S U M M E R , V O L U M E 3 Page 5 Is Your Viable Monitoring Program Compliant? There are several regulatory and compliance guidelines out there today that make it difficult to ensure your company is following the right ones. How do you know which ones to follow? How do you know when there are changes made to those regulations? How do you simply keep up with the dynamic changes in the industry and compliance issues? ISO (Cleanrooms and Associated Controlled Environments Biocontamination Control) This regulation focuses on a formal system to establish the environmental monitoring (EM) plan, sample locations, frequency and even guidance on how to do the viable sampling. It gives guidance to the industry for setting up an EM program as well as requirements for the incubation of samples, the appropriate medium to choose, the types of air samplers, and even setting up the alert and action levels based off of historical data rather than a set number for all. USP<1116> (Microbiological Evaluation of Cleanrooms and Other Controlled Environments) As of May 1, 2012, the new version of this regulation is in effect. It proposes that viable samples need to be analyzed as a whole within an area as well as frequency of viable sampling to determine if there is an issue or not. This regulation will focus on the sterile fill aseptic areas with no post-sterilization. It also outlines the methodology for sampling and analysis of each sample. The different types of recommended viable air samples are also listed. Micro-Clean utilizes one of these samplers, Surface Air System Sampler (SAS), as mentioned in the regulation. USP <797> (Pharmaceutical Compounding Sterile Preparations) Pharmacies and hospitals are the main concern with this regulation. Anyone compounding drugs (i.e. IV bags) would need to follow this regulation. The layout of where the compounding takes place is outlined to the classification in ISO Along with the room classifications, comes the gown qualification of personnel. All personnel performing compounding need to go through an initial gown validation then a routine qualification thereafter. All areas must undergo routine environmental monitoring to ensure the level of cleanliness in regards to microorganisms. These are just a few regulations that are key players in the pharmaceutical, medical supply, medical device, biotech and electronic industries. To stay up to date and help you stay compliant with the regulatory agencies, give us a call at Micro-Clean. We have experts that are ready to help any company, big or small, stay in the right path of compliance. Types of Air Viable Samplers Technology is changing everyday and every second, which in return provides a large variety of air samplers on the market. As per USP <1116> there are Sieve Impactors, Centrifugal Samplers (i.e. RCS Plus), and even Surface Air System Samplers (i.e. Super SAS 180). All are recognized by the regulation and within the controlled environment industry. You might be asking yourself, how do you choose the right one? The Sieve Impactors are apparatuses that have a container that is designed to hold some type of petri dish containing the appropriate medium Sieve Impactor of choice. The cover of these units is perforated to accommodate the type of plate underneath. Typically a vacuum pump is installed to pull air through the device and onto the medium. Depending on the size of the perforations, you will recover different types of organisms. The tubing itself that is connected to the pump could be a possible area of contamination if not maintained. Centrifugal Samplers are units that have propeller type designs that pull a p r e d e t e r m i n e d volume of air through RCS Plus the unit. As this is happening, the air is being impacted onto a strip of medium and then out. The medium strip also presents difficulty loading and unloading which could in return present contamination of the samples by the user. These types samplers are typically used in unidirectional airflow areas, and are designed to have the head of the unit placed against the direction of the airflow. The centrifugal air samplers also demonstrated selectivity for larger particles, in previous studies. This in turn recovers a higher number of organisms when compared to other air samplers. A type of sieve impactor is the Surface Air System Sampler. This unit is designed with a perforated entry section Super SAS 180 that accommodates the type of contact plate underneath the sampler head. Below the medium plate is the turbine that literally pulls the air through the perforated head, over the medium and beyond the turbine and motor where it is exhausted back out of the unit. This unit collects samples at a rate of 180 liters per minute, which is much higher than most other air samplers today. The r o o m f o r us er e r r or o r contamination is decreased due to the simplicity of the device, sampler head and medium of choice. Choosing the right air sampler for your application can be exhausting and troublesome. This breakdown is a brief overview of only a few samplers out on the market. The appropriate time needs to be taken to present all the pros and cons of each device for the particular application in each company. By choosing Micro-Clean as your environmental monitoring company, we can provide a wide variety of samplers to suit your facilities needs. We have multiple types of calibrated samplers as well as a number of each to take on any project size.

6 Page 6 Customer Training on Industry topics Micro-Clean, Inc. is proud to host our seminars on key areas of technical interest to our valued customers. This training has been requested by individuals and groups involved or associated with biological safety associations, industrial hygiene, and cleanroom regulatory agencies. The training is geared towards Design, Engineering, Facilities, Operations, QA, Regulatory Affairs, and Safety Professionals to have a greater understanding of the safety, containment, sterility and regulatory requirements of our industry. Our fall customer training seminars are as follows: Biological Safety Cabinet Training (NSF Standard #49) October 9, 2012 The standard in the United States for Biological Safety Cabinets (NSF/ANSI Std #49) has received numerous changes over the last five years. These changes have an impact on how we deal with BSCs. New installations are primarily affected, however there are occasions where retroactive changes are recommended or even required to maintain current industry safety and operations expectations. As a service to our valued customers, we are offering a training class to all individuals interested in learning about Biological Safety Cabinets and the updated standard. The class will be offered at our facility in Bethlehem, PA. Seminar trainers are very familiar with the many changes of the NSF standard. Therefore, we are capable of discussing issues pertaining to Biological Safety Cabinets. Laboratory Ventilation Management Seminar October 10, 2012 Using ASHRAE 110 Tracer Gas Analysis, Performance Evaluation and Balancing of Laboratory Chemical Hoods During the past few years, it has become increasingly clear that the practice of simply placing a Laboratory Chemical hood (formerly called a "Chemical Fume Hood") into a room and adjusting the face velocity to a magical number is no longer adequate. We are commonly called on to look at laboratory ventilation in a much more responsible manner. Recent litigation has made it dangerous not to take our responsibilities seriously. The cornerstone of these programs is a good understanding of relevant industry standards and guidelines including; ASHRAE , ANSI/ AIHA Z , and SEFA We will include both hands-on demonstration and lectures covering overall strategy and industry standards. Pharmaceutical Regulated Cleanroom and HEPA Filter Testing Two-Day Seminar October 11-12, 2012 Our Professional trainers will cover an array of topics on Cleanrooms and HEPA Filters. Below is a brief description of the topics that will be discussed over this two day seminar. The seminar is designed with practical learning in mind. Students will not only learn the theory in a classroom setting but they will also be able to apply their knowledge in our state of the art technical center. Course curriculum covers Understanding HEPA filters and filtration, understanding cleanrooms, types of airflow within the cleanroom and its testing methodologies, validating Critical Airflow Performance, Airflow Visualization and smoke studies, industry particle count standards, Room Pressurization and Recovery Tests, aerosol generators and filter leak testing, and a very informative Energy Savings Seminar. The two-day seminar includes many hands-on labs to reinforce the points of the lectures and provides for a very informative learning environment. Representatives from the Design, Engineering, Facilities, Maintenance, Operations and Safety departments will benefit from the classes. Interaction with your peer groups help you form strategies to deal with the new challenges in your organization. Micro-Clean s Technical Center allows us to demonstrate the issues that are discussed. We hope you take advantage of these very cost-effective and informative training seminars to better understand your use of Laboratory Ventilation, BSCs or Cleanrooms. Contact Debbie Laubach to reserve your seat. Phone x499 or debbielaubach@hepafilters.com

7 I N D U S T R Y N E W S Page 7 NSF/ANSI Biosafety Cabinetry: Design, Construction, Performance and Field Certification The NSF/ANSI Standard revision has significant impact on how older BSC installations are integrated into the laboratory environment, but the end result will be improved laboratory safety. Some of the substantial changes include: Stronger wording for converting existing A1/A2 hard-duct connections to canopy ducting. The hard-ducted A1/A2 cabinet is now considered as unacceptable. Any Type A1 or A2 cabinet when canopy connected shall have an audible and visual alarm notifying the user of a potential loss in canopy containment. The change to canopy monitoring may require modification of how exhaust alarms are installed in BSCs. Many current applications have the airflow alarm positioned to measure the airflow from the exhaust HEPA filter. While this may detect changes in the BSC exhaust, it will not detect a degradation of complete failure of the exhaust system. If you have any additional questions regarding Biological Safety Cabinets and how they need to be properly integrated into the Laboratory Ventilation System to meet the expectations of NSF Standard 49, please contact us or enroll in one of our upcoming Customer Training Seminars. The ISO Standard will provide filter manufacturers, suppliers and users with a single group of standards to classify and specify filter factory testing ranging from efficiencies of 95% to %. The standards are broken out into five sections: 1-Classification, performance, testing and marking 2-Test equipment 3- Testing of the flat sheet filter media 4-Constructed filter scan test method 5-Constructed filter efficiency test method While the ISO through -5 documents were based on the EN1822 standard it does not exclude other proven factory test methods used in the U.S. and other nations. The ISO Standard takes steps towards unifying factory test methods and away from national test methods.] One negative aspect of the ISO Standard is that it does not mesh well with real-world applications and needs such as HEPA filter specifications for the regulated pharmaceutical and biotechnology industries. Most cleanroom and containment device HEPA filters are specified with a minimum 99.99% overall efficiency and scan test penetration requirements of individual leaks cannot exceed 0.010% of the upstream concentration. Strictly going by the ISO Standard, most facilities would have to convert to a U % efficiency to achieve the individual penetration below the 0.010% regulatory requirement. Installing ULPA filters where HEPA filters have historically worked well for decades only adds additional problems to the filter buyer with higher filter differential pressure that come with higher efficiency ULPA filters and increased filter purchasing costs. With increased filter efficiency comes higher resistance across the filter and higher operating costs. Filter purchasers can specify alternative local penetration values taking into account how the industry expects the filters to be tested. An aerosol photometer and Laskin or thermal generator are commonly used in the pharmaceutical and biotechnology industries. Selecting an ISO 45 H or U % efficiency with a 0.008% individual penetration requirement will typically work well in this application. This filter specification is similar to the IEST-RP-CC001.5 Type K HEPA filter. You, as the filtration system owner, need to ensure that the filter manufacturer makes the filter to the specification that you want based upon your use and testing application. If you allow the filter manufacturer to dictate what they think you need, you may end up with filters not appropriate for your needs, may fail the certification HEPA filter integrity leak test, or may affect your facility s air handling system delivery capabilities. The tail should not wag the dog. ISO through High Efficiency Filters and Filter Media for Removing Particles from Air. The five documents became official ISO Standards in October If you have any filtration questions, please contact our filter sales professionals so we can assist you in providing or recommending the proper filtration for your application.

8 Page 8 Visit us on the web! and at MICRO CLEAN, INC. 177 N Commerce Way Bethlehem, PA Phone: TO OUR CUSTOMERS Micro-Clean s expansion to New England is now at full throttle. The reception to the area has been exceptional and we are eagerly implementing new services, products and efforts for not only New England, but all of the Micro-Clean territories. The expansion into Nanotechnology with our Luma-Guard Products has been a massive hit as well and one you will certainly want to include within your chosen group of Micro-Clean Services. We have developed the most well-rounded, highly trained and experienced company in the industry and look forward to continuing to service your needs in the future. Fax: John Wagner info@microcln.com President / CEO Micro-Clean, Inc. PROVIDING EXCEPTIONAL SERVICE SINCE 1974 ISO 9001:2008 CERTIFIED ISO 17025:2005 ACCREDITED