Environmental Monitoring Program for Clean Room

Environmental Monitoring Program for Clean Room Bioburden and ETO limits Environmental monitoring program for a class 9 clean room that manufactures enteral feeding sets Abstract A clean room is an internal clean environment that is often used for manufacture or scientific research with a low level of environmental pollutants such as air bourn microbes, dust or chemical vapors. A clean room has a controlled level of contamination that is specified by the particles that are permitted per cubic meter and also the size of the particles is specified. A clean room has a special meaning that is defined by the International Standards Organization (ISO). ISO has defined a clean room as a ‘room in which the concentration of airborne particles is controlled and which is constructed and used in a manner to minimize the introduction, generation and retention of particles inside the room and in which other relevant parameters, e.g temperature, humidity and pressure are controlled as necessary’. Clean rooms are usually supplied with air that has been filtered through high efficiency air filters. This air is then changed a number of times depending on the class and purpose of the clean room. A clean room is built with materials that do not generate particles or outgas airborne chemical contamination and can be cleaned easily. Finally personnel that operate inside the clean room where protective clothing knows as bunny suits to minimize their dispersion of particles and microorganisms. An enteral feeding tube provides a means of maintaining nutritional intake when oral intake is inadequate or when there is restricted access to the gastrointestinal tract, eg owing to obstruction. ETFs are now commonly used for a wide range of clinical conditions and across a wide range of people (Rebecca White, Vicky Bradnam ,Handbook of drug administration via enteral feeding tubes, 2007) .Enteral feeding devices include enteral feeding pumps, pump sets, enteral feeding tubes and kits. Enteral feeding is often used to supply patients with nutrition who cannot consume by swallowing. Patients may not be able to consume by swallowing due to injury or illness such as pancreatitis, cancer and malnutrition. Introduction Cleanrooms are monitored according to two well-known standards, ISO 1644-1 and Federal standard 209E. Federal Standard 209E is the standards that the USA comply with whereas ISO 1644-1 are the standards that are applied internationally. ISO 14644 part 1 has been revised as a new second edition draft international standard ISO/DIS 14644-1.2(2014). ISO 14644-1 is part of a series of documents concerned with cleanrooms and associated subjects. This part of ISO 14644 specifies the classes of air cleanliness in terms of particle concentration in air volume. It also specifies testing methods that are used to determine classification. These include selection of sampling locations and evaluation of class from the data collected. The most significant change in this new set of standards is the use of a more consistent statistical approach to the selection and the number of sample locations and the evaluation of data collected. The statistical confidence is calculated based on the hypergeometri c distribution. Non-Viable Particles-Air Microbial Contamination-Air and Surface Pressure differential Water quality Temperature and Humidity Annex A There are a number of test parameters that ISO state that have to be tested when testing the air in a clean room. These recommended tests are listed in Annex A. Annex A provides the recommended tests and the recommended order in which to carry them out .The parameters are listed as follows. Airflow test, Air pressure difference test, humidity test, temperature test, particle disposition test, installed filter leakage test, Airflow directional test and visualization, Airborne particle test for macro particles, Airborne particle test for ultrafine particles, Electrostatic and ion generator test, Particle deposition test, Recovery test, Containment leak test. A checklist is provided to assist in testing criteria. This check list in encoded Annex A. Annex A also gives a series of recommended tests when sampling. 5. Test report The result of each test should be recorded in a test report and the test report should include the following information: Name and address of the testing organization and the date which the test was carried out. Number and year of publication of this part of ISO 14644. Clear identification of the physical location of the clean room or clean zone tested, and specific designations for coordinates of all sampling locations. Specific designation criteria for the clean room or clean zone, including the ISO classification, the relevant occupancy state and the considered particle size. Details of the test method used and identification of the test instrument and it’s current calibration certificate. Test result, including data reported as specifically required in the clause of Annex B, and a statement regarding compliance. Any other specific requirements defined relevant to the clause of Annex B. A.1 General The test procedures that are used in this part of ISO 14644 may be used for demonstrating compliance with the performance criteria of a user specified installation and for performing periodic testing The choice of tests are usually based on the required level of classification, operational states and the design of installation. Table 1 provides optional tests that are recommended by the international standards organization and table 2 is the bioburded limits provided by ISO for a class 9 cleanroom. Annex B (B.1.1) This test method is a specification of the measurement of airborne particle concentrations with size distributions having a threshold size between 0.1 micrometer and 5 micrometers. Measurements are often made according to three defined occupancy states. These occupancy states are as follows; as-built, at rest and operational. The measurements are made to verify the cleanliness classification in accordance with ISO 14644-1. (B.1.2.1) This part of Annex B is known as B1. The location selection, sampling points, clean zone classification determination and the quality of data required should be in accordance with ISO 14644-1. One of the main aspects of B1 is to provide reference methods. Annex B also provides a risk assessment for the clean room. >/= 0.1 um >/=0.2um >/=0.3um >/=0.5um >/=1um >/=5um (B.1.2.2) Procedure for airborne particle count ISO recommends the installation of a DPC intake at a specified sampling location. In sampling locations where the airflow is not controlled or predictable the inlet of the sample probe should be directed vertically upwards. The transit tube from the sample probe inlet to the DPC sensor must be as short as possible. If samples that are greater than or equal to one micrometer, the transit tube must not exceed the manufactures recommended length and diameter. B3 Airborne particle count for macroparticles The test methods that are described here are for the testing of particles larger than 5 micrometers in diameter. Measurements for macro-particles can be made in any of the three occupancy states of a clean room. These measurements are made in order to determine the concentration of macro-particles. B.3.3 Measurements methods for macroparticles ISO has assigned two general categories for macro-particles, therefore comparable results may not be produced if different measurement methods are used. Therefore correlation between different methods is not possible Collection by filtration or inertial effects, which is then followed by microscopic measurement of the number and size, or measurement of the mass of collected particles. (1). Filter collection and microscopic measurement (B.3.3.2.1) will report macro-particles using particle size based upon the agreed diameter. (2). Cascade impact collector and microscopic measurement will report macro-particles using particle size base upon the microscopists choice of reported particle diameter. (3). Cascade impact collector and weight collector will macro-particles using particle size based upon an aerodynamic diameter. (b). In situ measurement of the concentration and size of macro-particles with a time of flight particle counter or a DPC. (1). DPC measurement will report macro-particles using particle size based upon an equivalent optical diameter. (2). Time of flight particle size measurement (B.3.3.3.3) will report macro-particles using particle size based upon an aerodynamic diameter. B.3.3.3 macro-particle measurement without particle collection B.3.3.3.1 Macro-particles can be measured without collecting particles from the air. This process involves the optical measurement of the particles that are suspended in the air. An air sample is taken through a DPC, which reports either the equivalent optical diameter or the aerodynamic diameter of particles. B.3.3.3.2 Discrete particle counter (DPC) measurement. The procedure is the same as in B.1. DPC does not require sensitivity for detection of particles that are less than 1 micrometer. Care is required in order to ensure that the DPC samples directly from the air at the sample location. If sample tubes are longer than 1 meter to the DPC then they should not be used. The DPC often has a sample flow of 0.00047 m^3/s and should be fitted with an inlet sized for isokinetic sampling in unidirectional flow zones. The DPC should be set facing upwards in areas where non-unidirectional airflow takes place. The DPC size range settings are established so that only macro-particles are detected. B.3.3.3.3 Time of flight particle size measurement The dimensions of macro-particles can be measured by using a device that is known as time of flight apparatus and accelerated through a nozzle into a partial vacuum, where the measurement region is located. Any particles that are in the air sample will accelerate to match the air velocity in the measurement region. It is this relationship between the air velocity and particle velocity at the point of measurement that can be used to determine the aerodynamic diameter of the particle. B.3.4 Procedure for macro-particle count The sample inlet probe must be set up on the selected apparatus. The required air volume must be sampled to collect at least 20 macro-particles at each sample point and make measurements as specified in ISO 14644-1 or ISO 14644-2. The M-discriptor concentration in the selected particle size ranges must be calculated as agreed between customer and supplier, and report the data. B.3.5 Test reports The following information and data should be recorded as described in clause 5. (a). Definition of the particle parameter to which the apparatus responds (b). Type of measurement: classification or test M descriptor determination or monitoring (c). Type designations of each measurement instrument and apparatus used and it’s calibration state. (d). Cleanliness classification of the installation (e). Macro-particle size range(s) and the count for each size range reported (f). Apparatus inlet sample flow rate and flow rate through sensing volume. (g). Sample point locations (h). Sampling schedule plan for classification or sampling protocol plan for testing (I). Occupancy state(s) (j). Stability of macro-particle concentration, if required (k) Other data relevant for measurement.

Jeannine :: Personal Narrative Papers

Jeannine She had seen things and experienced a life that I only knew about through the movies. She acted as though she knew I would not be able to understand her, but I could see in her eyes that she hoped I could. e stood in the driveway, physically closer than we had been to each other in two weeks. Jeannine, my sister, did not stay at home too much anymore. She had dedicated her existence to her boyfriend Steven and chose to live with his family so that the two of them could be closer. My parents were supportive and open, but they would never have let their seventeen year old daughter sleep in the same bed under their roof with her nineteen-year-old boyfriend. So after countless years of tension and arguments, my sister had achieved what she had sought for years, independence from her family, but most of all from her older brother. Now standing in that driveway, our childhood playground, as I prepared for the long journey to James Madison University, we realized that the past five years of our lives had been wasted. Her constant struggles to get out of the house coupled with my harsh attempts to see that she met that goal consumed our adolescent years, the period where we needed each other the most. My parents told me that they were ready to leave, and I gave Jeannine a long hug. It was the first time in half a decade that I gave her a meaningful show of affection. I met her with the love that I had suppressed for so long, rather than the hate and loathing that was quick to my aid in the many years of confrontation that we shared. It was then, as her head rested on my chest and her arms wrapped around me, that I realized the wrongs I had done to her. All of a sudden, I did not want to leave. I had my sister back, how could I abandon her again? No one can really claim to have a perfect childhood sibling relationship, but we were still very close. At times, we could even be proud of one another. Yet, as in all sibling bonds, these good tidings never lasted. Our games of tic-tac-toe or kickball with our friends would go from friendly backyard, Little- House-on-the-Prairie type moments to screaming matches in a matter of days. Jeannine :: Personal Narrative Papers Jeannine She had seen things and experienced a life that I only knew about through the movies. She acted as though she knew I would not be able to understand her, but I could see in her eyes that she hoped I could. e stood in the driveway, physically closer than we had been to each other in two weeks. Jeannine, my sister, did not stay at home too much anymore. She had dedicated her existence to her boyfriend Steven and chose to live with his family so that the two of them could be closer. My parents were supportive and open, but they would never have let their seventeen year old daughter sleep in the same bed under their roof with her nineteen-year-old boyfriend. So after countless years of tension and arguments, my sister had achieved what she had sought for years, independence from her family, but most of all from her older brother. Now standing in that driveway, our childhood playground, as I prepared for the long journey to James Madison University, we realized that the past five years of our lives had been wasted. Her constant struggles to get out of the house coupled with my harsh attempts to see that she met that goal consumed our adolescent years, the period where we needed each other the most. My parents told me that they were ready to leave, and I gave Jeannine a long hug. It was the first time in half a decade that I gave her a meaningful show of affection. I met her with the love that I had suppressed for so long, rather than the hate and loathing that was quick to my aid in the many years of confrontation that we shared. It was then, as her head rested on my chest and her arms wrapped around me, that I realized the wrongs I had done to her. All of a sudden, I did not want to leave. I had my sister back, how could I abandon her again? No one can really claim to have a perfect childhood sibling relationship, but we were still very close. At times, we could even be proud of one another. Yet, as in all sibling bonds, these good tidings never lasted. Our games of tic-tac-toe or kickball with our friends would go from friendly backyard, Little- House-on-the-Prairie type moments to screaming matches in a matter of days.

Hamlet’s Emotions in the First Soliloquy Essay

In the play Hamlet, Shakespeare creates a rich emotional fabric in Hamlet’s first soliloquy. From the first lines of the soliloquy, we can find such emotions as depression, disillusion, anger, and even the hatred and disgust for Hamlet’s mother and uncle. The first line in the soliloquy shows us depression: â€Å"O! that this too too solid flesh would melt,/Thaw and resolve itself into a dew† (Shakespeare 42). Hamlet’s depressive spirit is explained by that he is tired of life and wants to die. The reason for this is that all of the events, like King Hamlet’s death or Claudius’s marriage with Gertrude, Hamlet’s mother, which happens with the Prince press on him. As for the being disillusion about the Queen, when she marries Claudius, Hamlet asks himself â€Å"why, she would hang on him,/As if increase of appetite had grown† (Shakespeare 42). Hamlet feels disillusioned about his mother because after two months when his father dea d, she married Claudius. In Hamlet’s opinion his mother betrayed his fathers love. Also Hamlet feels too angry with his uncle, so he compares Claudius with his father, who was â€Å"so excellent a king† and says about the new king â€Å"that was, to this,/Hyperion to a satyr† (Shakespeare 42). The young Prince can’t understand how his uncle can be a better king than his father. Hamlet is angry with Claudius because that â€Å"satyr† married his mother and called Hamlet his son, without asking his opinion or wish. Hamlet is not only angry with his uncle, but also he hates Claudius: â€Å"My father’s brother, †¦/within a month,/Ere yet the salt of most unrighteous tears/Had left the flushing in her galled eyes† (Shakespeare 44). Hamlet hates his uncle because Claudius seduced his mother. But the strongest emotion Hamlet has in my mind is disgust about his mother: â€Å"a beast, that wants discourse of reason† (Shakespeare 42). Young Hamlet thinks that his mother betrayed his father love while marrying Claudius. Also Prince thinks that his mother is like all other women, he thinks that she is a prostitute. In the first soliloquy Hamlet has a rich emotional fabric, which is made up from the strongest emotions that form Prince of Denmark’s character.

Mary Shelley s Frankenstein And The Bride Of Frankenstein...

It is amazing how words on a page take a life of their own once they are written. An author s story can take readers away on a magic carpet ride, to a magical castle that anything can happen in Britain, even through a wardrobe to a land far away and draft them in the battle of a lifetime. But what is even more fascinating is that unlike humans, the words on the page never changes. From this moment to 200 years from now, the words on this page will always be the same, it is only the reader and the world around them that changes. Take for example Mary Shelley’s Frankenstein. In 1818, Shelley had a nightmare that lead her to write her novel as a personification of the Victorian Culture’s fascination of science and death. In 1934, director James Whale adapted the material into â€Å" The Bride of Frankenstein† film, and was an allegory for pre-WWII unity, then in 1997, someone interpreted the film as a homosexual allegory for the 1990’s. This paper will examin e how Mary Shelley adapted her nightmare into an allegory for her Victorian era audience, how James Whale used her original text to turn â€Å" The Bride of Frankenstein† into a message of unity for a pre-WWII audience, as well as how Garry Morris uses Whale’s film to create a pro same sex marriage message out of the text in 1997. Mary Shelley adapted her nightmare of a mad scientist bringing a dead body back to life, into a text that reflects Victorian Customs is by featuring the importance of education in Victorian society asShow MoreRelatedAnalysis Of Mary Shelley s Frankenstein 1028 Words   |  5 PagesFrankenstein thinks that everything is alright now, but Elizabeth has a premonition that the monster will return, and she warns her fiancà © that she fears some harm is going to befall him. At the same time, during the entire village’s celebration, the father of the dead girl carries her lifeless body though the streets for all to see. 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