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5 Reasons Why Your Business Needs Gloves side leakage machine?

Author: Liang

Nov. 04, 2024

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What is a Glove Leak Tester? Understanding Glove Integrity ...

A glove leak tester is a piece of equipment that proves very helpful in determining the ability of gloves to protect one against contamination in an area where such conditions are needed. Such a tool applies in areas like pharmaceuticals and healthcare, where such devices require a sterile environment to protect both the products and the users from harm. This testing of glove integrity will help properly detect any faults or leakages that the gloves may pose and ensure they are safe to use. This is important to ensure that there is no risk of contamination and, hence, ensures the safety and dependability of the operations in such crucial fields.

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Understanding the Key Principles of Glove Leak Detection

1. Fundamental Theory &#; Ideal Gas Law.

PV=nRT.

P &#; Pressure
V &#; Gas Volume
n &#; Amount of Gas (Moles) R &#; Gas Constant
T &#; Gas Temperature

2. Isobaric Process: The pressure of a gas with a fixed mass remains constant, Gay- Lussac&#;s Law:

(1). Qualified Gloves:

For qualified gloves that do not leak air after inflation, the internal pressure of the glove remains constant. When initially inflated, the gas temperature inside the glove is lower than room temperature. The glove passes through the first laser displacement sensor at room temperature, which records a diameter measurement. After 20 seconds, the glove reaches the second laser displacement sensor. During this period, the temperature inside the glove gradually increases due to the room temperature, causing the glove&#;s diameter to also change (increase).

(2). Gloves with Small Pinholes:

Due to the glove&#;s elasticity, the diameter will decrease within 20 seconds when there is a slight leakage. However, the internal pressure of the glove will not change significantly. Only after a long period of leakage, when the glove loses its elasticity, will there be a change in the internal pressure of the glove!

What is the Purpose of and How Do We Use a Glove Leak Tester?

A glove leak tester is an airtight instrument used to evaluate the performance of various forms, particularly protective gloves used in different industries, mainly pharmaceutical and laboratory. The tester works by identifying micro-holes or leakages that invalidate the integrity barrier. The gloves are intended to provide increased safety to the users and compliance to the industry.

What is the Purpose of a Glove Leak Tester?

The most important and simplest purpose of leak testing is to verify that personal protective equipment (PPE) and, most of all, gloves do not pose risks due to intolerable defects. By employing leak testing, facilities can reduce contamination likelihood, guarantee effective barrier protection, and meet health and safety requirements. Periodic testing encourages the observance of safety and assurance of reliable operation with such delicate materials.

How Does a Glove Integrity Tester Operate?

The glove integrity tester detects leaks; in this respect, leak testing may be performed using a vacuum or pressure. The testing glove is either expanded by forcing pre-measured air inside it or vacuuming it. It is then monitored for any reduction in air pressure or vacuum or any air escaping from the glove as indicative of a compromise in integrity. This effective approach enables the leakage detection of visually undetectable risk factors.

View full operating instructions &#;

What Are the Distinct Features of an Automatic Glove Tester?

Automatic glove testers offer several new features that help increase productivity and task accuracy. These include automated test numbers, adjustable settings for pressure and vacuum, working and debugging functionalities, and friendly user operations. Most models also include data logging capabilities to help manage compliance and operational aspects over time.

Why is Glove Integrity Testing Important in Pharmaceutical Applications?

Glove integrity testing is one of the most critical components in pharmaceutical areas to protect products and workers. Ensuring the gloves have no perforations or tears is vital because it helps avoid contamination when dealing with delicate substances. This practice is essential for meeting global guidelines and complying with an industrial culture that supports the well-being of people and upholds the quality of PD products in the market.

What Are the Risks Associated with Glove Leaks?

Glove leaks cause great risks to pharmaceutics, majorly by construction enabling cross-contamination. In the case of acceptance and using compromised gloves, the barriers are rendered useless, and toxic gases, dirty water, or germs, in one way or another, find a way into the product and the employees, respectively. In addition, the risks of leaks may cause litigation, noncompliance, and damage to a firm&#;s image, hence making it necessary to carry out thorough gliomatosis.

How Does Glove Integrity Impact Aseptic Environments?

Especially in aseptic environments, glove safety is very central to the maintenance of sterility in those literal areas. Whenever a glove breaches aseptic techniques, aseptic products will be contaminated or worse 3 D Psycho 24:3D handling and annex of many. Letting in controlled areas facilitates sleeper agents where bacterial membranes or particulates may compound, leading to risks to patients and infringement of the law by health regulators. Therefore, rigorous tests enable assurance of the efficacy of these gloves where preservation of cleanliness is concerned.

Which Determining Standards Are Relevant to Glove Testing?

Various compliance standards govern glove testing in the pharmaceutical industry, such as ISO , which deals with requirements for quality management systems, and ASTM D, which provides guidelines on assessing glove leaks. Furthermore, the quality control processes endorsed by FDA regulations ensure that the gloves produced are safe and effective. Such regulations are essential as they help certify the relevant facilities and operational compliance.

What Types of Glove Leak Testers Are Available?

Different glove leak testers seek to verify the tightness of gloves utilized during pharmaceutical manufacture. This equipment can be collagenized into manual and mechanical testing systems depending on their operational purpose and measures to be taken. Knowing how these testers are differentiated is key in recommending the best to withstand the demanding quality assuredness processes.

What is the difference between manual and automated glove testers?

Manual glove testers are those in which the operator does the leak test. Usually, this involves water immersion of gloves and checks if any bubble comes out. This test, albeit effective, tends to take a lot of time and may add an element of risk. Automated glove testers are such that leaks are detected through machines, and the operator&#;s hand does not interfere with the detection process; therefore, the results are more reliable and effective in quality and speed as far as operations are concerned.

What are the advantages of wireless glove integrity testers?

Wireless glove integrity testers provide more advantages in performance areas such as telemetry besides flexibility and convenience. This allows quick intervention and corrective action, such as closing the said area if leaks are observed. The mobility of this equipment makes it possible to test in other areas of the facility without being restricted to one testing area. This improves performance and helps meet the high level of safety and health requirements that are in place.

What is the impact of isolator gloves and sleeves on testing?

Gowz habit gloves and sleeve hardware units are essential in maintaining the aseptic conditions in isolators. Still, they can interfere with glove integrity testing since they have dynamic movements that are different from normal gloves. Such mechanical tests are considered when analyzing material properties since their thickness and flexibility do not allow for normal testing procedures. To that end, these items are bound to require special clamping tests to ensure the sealed items perform the duties demanded by protection standards.

What are the procedures for repairing and adjusting the glove leak tester?

Routine maintenance and adjustments are mandatory when the glove leak test equipment is used. Proper upkeep includes regular maintenance such as servicing, checking, and fixing cited components and following recommended best practices. This helps to check for any damage to the equipment or repairs as early as possible, extending the equipment&#;s life and the tests&#; accuracy.

What needs to be done to glove testers?

When maintaining glove testers, one must ensure that all circuit mechanical elements are carefully examined for wear and that connectors and seals can hold pressure. It is also important that procedures directed towards policy protection are the cleanup of the chamber for testing and the outer surface. Also, there is a need to make Software American operational mechanics for the imaging performance for the users, which also includes software and calibrations to ensure they are up to the standards.

What steps are taken to ensure that the searched standards are observed?

Yes, the dependence on procedural compliance with the calibration standard is based on the documentation process and the completion of each step as outlined. Testing behaviors compliant with the regulation require that the results of tests performed be compared with known values. Testing must be performed using calibrated equipment whose calibration can be traced, and those carrying out the testing must be trained on the processes followed. Keeping records from conducting different calibration activities makes it easier during reviews. Also, it assures that the glove testers function within acceptable limits to ensure the safety of the products.

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What Related Products Enhance Glove Integrity Testing?

Adding more products into the glove integrity testing enhances both structures and assessments of testing processes. Auxiliary products, in this case, automated testing systems, data management software, and environmental monitoring systems, are catalysts for efficient infusion of processes and understanding of glove performance.

How do integrated systems improve glove testing efficiency?

Integrated systems enhance glove testing efficiency by delegating laborious tasks to devices, retaining only important operations that eliminate human error. These systems facilitate monitoring and data acquisition promptly, reducing the time required to analyze and prepare a report. In addition, the interconnectivity of devices allows storage of results in one location where they can be accessed to take appropriate actions on the reports, thereby reducing the time taken by quality control.

What specifications and guidelines should you keep in mind for glove testing systems?

To ascertain the values regarding glove testing systems, the parameters to be determined are test pressure range, degree of sensitivity, and detection. In addition to this, be careful to confirm that the system meets the necessary codes. It is also very important to analyze the ease of the system&#;s design and maintenance and the resulting data because these factors will affect the overall performance of the tests.

What factors should be considered so the glove leak tester fulfills its intended purpose?

Establishing a glove leak tester tends to be a rather simple task, yet it has very important implications. The task is to analyze statistical models to find the best profile compatible with the company&#;s operational strategy, the surroundings for testing, and the legal requirements that must be fulfilled.

What factors should determine which glove tester is most suitable for this purpose?

When looking for a glove leak tester, important considerations include the types of materials to be tested, the maximum and minimum pressure involved, and the required overall sensitivity. No home equipment is pristine, and most users have other installations that need to be recognized with the additions made to the written test and obvious testing on some standards. Also, pay attention to product usability, maintenance, and guarantee terms to achieve the best performance and service results.

Which specific features will enable the monitoring of glove testers concerning various types of glove testers?

When monitoring glove tests, compare parameters such as detection measure, test velocity, and total effectiveness. Check the calibration methods used to determine whether they align with the set standards. Customer reviews, expert reviews, and independent test results have addressed such issues. Ultimately, it will also be wise to do test trials on the various models for first-hand experience before deciding which model to purchase.

Frequently Asked Questions

&#;&#;

Q: What is a Glove Leak Tester, and how does it function?

A: A Glove Leak Tester is an instrument specifically made to check the proofing of glove ports in an isolator or Restricted Access Barrier System (RABS). It performs a leak test of a container, which is tested only by this method&#;pressure decay&#;right before reaching standard compliance like ISO -7.

Q: How does the wireless and pipeless feature of the Glove Leak Tester enhance its functionality?

A: The Glove Leak Tester&#;s wireless and pipeless design promotes greater functionality and portability during the application. It eliminates cumbersome connections, making it easy to incorporate into normal processes while ensuring that the archiving of testing data is intact.

Q: What are the advantages of using a Glove Leak Tester designed for simplicity?

A: A Glove Leak Tester designed for simplicity always has an easy-to-navigate interface that facilitates the user&#;s operation. This simplicity of operation facilitates shorter learning periods for the operators, faster and more efficient test procedures, and decreased mistakes during leak testing operations.

Q: Can you explain the significance of full traceability in leak testing?

A: Full traceability in leak testing is very important because it is very valuable in ensuring that all the tests can be accounted for and traced. This is more so in the pharmaceutical sector, where one has to adhere to regulations such as CFR Part 11. It gives the testing record for glove and sleeve integrity&#;s passive integrity over some time.

Q: What is the purpose of using a pressure decay method in leak testing?

A: The principle of pressure decay is a method that is applied in combination with leak detection to assess leakage in joints and evaluate the size of the leaks by observing leakage within a defined chamber or volume over time. When pressure drops below a specified level, it usually suggests a leak, so if that happens, steps can be taken to rectify the situation.

Q: How does the Glove Leak Tester comply with ISO -7 standards?

A: The Glove Leak Tester has been developed according to ISO -7 requirements, the standard concerning clean zones. The device agrees with the standards in Annex E.5, thus enabling easy verification of glove and sleeve integrity without contaminating the controlled environment.

Q: What is the recommended frequency of performing a glove and sleeve integrity test?

A: Glove and sleeve integrity tests are beneficial and should be performed regularly without failure to meet compliance. Operating parameters and processes in a given facility tend to govern the testing intervals.

The Need for a Glove-Use Management System in Retail ...

According to recent data from the U.S. Centers for Disease Control and Prevention (CDC), more than 60 percent of all the reported foodborne disease outbreaks in the United States are attributed to retail foodservice establishments.[1] As reported previously, failures to handle and prepare food safely in these establishments are the primary contributing factors that lead to foodborne disease outbreaks. The majority of the food safety hazards that exist in these establishments and their related probability of occurrence are well-known. According to the U.S. Food and Drug Administration (FDA) and CDC, the top five risk factors that contribute to the most foodborne disease outbreaks in foodservice establishments are:

1.    Improper hot/cold holding temperatures of potentially hazardous foods

2.    Improper cooking temperatures of food

3.    Contaminated utensils and equipment

4.    Poor personal hygiene

5.    Food from unsafe sources

Scientific studies have also validated these factors, and there is continual evidence that the lack of their control leads directly to foodborne disease outbreaks from retail foodservice establishments.[2] One scientific study showed that certain local health department inspection violations (each related to the top-five risk factors) were more likely to be associated with restaurants that had actually caused foodborne disease outbreaks in Minnesota.[3] When the authors compared these violations with contributing factors of foodborne illness as defined by CDC,[4] they found that about two-thirds of the top violations observed during inspections at restaurants associated with outbreaks fell into the &#;&#;contamination&#;&#; category&#;for example, contamination of hands, surfaces, and food.

Why No Bare-Hand Contact?
Contamination of foods via the hands ranks highly among the contributing factors identified during outbreak investigations. In a report on the factors contributing to foodborne disease outbreaks from to ,[5] bare-hand contact, inadequate cleaning of processing or preparation equipment or utensils, and handling of food by an infected person or an asymptomatic carrier were among the most important factors (associated with 26%, 25%, and 22% of disease outbreaks, respectively). Foodborne pathogens with low infective doses may be present on hands in high numbers and can be easily transferred to foods, food contact, and nonfood contact surfaces, necessitating barriers to transmission.[6&#;8]

According to FDA, when hands are contaminated or soiled, effective hand hygiene (HH) practices may not be sufficient to prevent the transmission of transient pathogens from the hands to ready-to-eat (RTE) foods.[9] The FDA Food Code discourages bare-hand contact with RTE food and recommends the use of suitable utensils, deli tissues, single-use gloves, or dispensing equipment when handling these food items.[10] The majority of individual state food codes have adopted and enforce this rule.[11] The obvious objective in utilizing gloves in foodservice is to minimize physical, chemical, and microbiological contamination of food. Gloves can unfortunately offer a false sense of security both on the part of food workers and food safety managers when employees are not trained and glove use is not supervised properly.[12]

Improper Glove Use Increases Risk of Foodborne Disease Outbreaks
Although gloves (single-use and reusable) can be an effective tool to prevent cross-contamination of RTE foods from hands, improver glove use can actually increase this risk. In studies by the CDC Environmental Health Service (EHS-Net) and others between and , around 16 percent of foodborne outbreaks implicated contaminated gloves or glove cross-contamination as a contributory cause.[13&#;17] A trend analysis of both gloved- and bare-hand contact, implicated as contributing factors from the time that glove rules were set into effect across the U.S. (&#;), shows a steady rise in percentages for both modes of cross-contamination.[18] Bare-hand contact was shown to be 15&#;18 percent higher (Figure 1). Taking model simulation results into consideration, a predictive cause for glove cross-contamination is quite likely on its way toward 20 percent or higher, based on the degree of variability and uncertainty presented by the data involved.[10] Trend analysis for the period from to and probably beyond indicates that current glove-use patterns, limitations, and relaxation of no-bare-hand contact rules (the &#;glove mandate&#;) due to glove failures could result in increasing numbers of foodborne illness outbreaks caused by gloves or glove cross-contamination. Affecting this would be improved glove types and management approaches designed to reduce cross-contamination risks.

The highest-risk glove/hand cross-contamination activity occurs when the same gloves are used to handle contaminated raw protein, then the employee touches food contact and nonfood contact surfaces (Figure 2), resulting in cross-contamination of food.[19] When food handlers touch raw proteins like chicken or ground beef and then touch other surfaces in the same kitchen, they can spread foodborne disease pathogens to these surfaces, where they can be &#;picked up&#; by the hands (with and without gloves) of other food handlers. Likewise, when a food handler switches tasks between handling raw and RTE foods and changes their gloves without washing their hands and forearms properly, they will contaminate the new pair of gloves because they have to touch the gloves to put them on. This can be a significant means of cross-contamination of RTE foods.[20] 

In a study of 18 independent delicatessen operations, widespread microbial contamination (Escherichia coli, Staphylococcus aureus) was found on turkey, cream cheese, lettuce, and food contact surfaces.[21] A subsequent review of health inspection observations revealed that there was 1) inadequate HH, 2) no gloves used, 3) improper single-glove use, and 4) inadequate glove changes in 39 percent, 33 percent, 28 percent, and 67 percent of these delis inspected.[13] Other glove-use behaviors have been identified that cause cross-contamination when gloves are worn for long periods of food prep and not changed when punctured or contaminated.[21&#;23] Additionally, pathogens can be found to adhere better to the surface of gloves worn by food employees when gloves fit poorly or are not changed regularly.[24&#;28]

The use of gloves does not reduce the need to ensure proper handwashing before and after glove use. Because hands, like other surfaces, can become coated with oils, grease, and fats, for example, they should be both cleaned and sanitized, just as a food contact surface is cleaned and sanitized. This is especially important during use of foodservice gloves. The effective use of gloves depends on selection of the right glove type and maintenance of the glove barrier integrity. Undetected glove microperforations are a frequent occurrence. Microorganisms penetrate gloves via the microperforations under conditions of normal use. Puncture occurrence is directly related to duration of wearing and puncture hazards of procedures. With the interior of gloves presenting a warm, moist environment for microbial growth,[29] it is easy to understand why glove leaks would double cross-contamination risk. Handwashing is an important first step before every glove use, but preventing glove leaks is critical to ensure the final barrier between hands and foods is maintained because even with a prior handwash, interior glove counts of bacteria can be more than a million organisms.[30]

A glove puncture has been described as a &#;liquid bridge&#; of microbial contamination that can flow to food contact surfaces and foods.[31,32] Studies have shown that thousands of Staphylococcus bacteria can pass through a single glove hole during a 20-minute period, even though the hands were scrubbed prior to gloving.[9] Likewise, excess moisture buildup can release microbial contamination present in the difficult-to-clean fingernail regions that can then be spread all over the hand within the glove.[12,33&#;35] Leaks don&#;t just go in one direction out of the glove; they can also lead to permeation of microbial species, food debris, and chemical residues into the glove interior, leading to an increase in microbial load and chemicals that can then be released onto food and food contact surfaces.[36,37] This emphasizes the need to wash hands when they become contaminated with these soils, sometimes both before and after glove use.[12,38,39] Facility sanitizer chemicals, alcohol-based hand sanitizers (some but not all), or extreme temperature exposure can weaken glove material integrity[36,39,40] and thus, under conditions of use, should be monitored as part of the food safety management systems (FSMSs) outlined below.

Importance of FSMSs
The best means to prevent cross-contamination of foods is to ensure that all food contact surfaces are deep-cleaned and sanitized before food preparation, raw animal food prep is separated from RTE food prep, food handlers wash and sanitize their hands before glove use and do not handle RTE foods with bare hands, and the establishment has a monitoring and corrective action management system based on process Hazard Analysis and Critical Control Points (HACCP) principles to achieve active managerial control of cross-contamination.[41&#;43]

A FSMS to manage single-use gloves (a glove-use management system) employed along with handwashing can be an effective means to decrease the transfer of foodborne pathogens from the hands to food contact and nonfood contact surfaces and to food.[43]

A glove-use management system can be developed to include:

&#;    Choice of the correct glove that with a specific glove-change frequency and type of foods prepared will minimize the risks related to undetected punctures

&#;    Different-colored gloves for when employees handle/prep raw animal proteins versus RTE foods to provide a visual cue to managers for proper glove use and reduction of cross-contamination of food contact and nonfood contact surfaces from gloves

&#;    Suggested raw animal protein-handling glove colors:

  •     Yellow: raw poultry (chicken, turkey, etc.)
  •     Red: raw meats (beef, pork, etc.)
  •     Pink: raw seafood
  •     Green: raw produce

&#;    RTE foods glove colors:

  • Clear, blue, or purple: all foods that will not undergo a kill or wash step to remove foodborne disease pathogens; use of colored gloves can provide a safety indicator to aid in preventing glove parts&#; ending up in food products

    [

    4]

&#;    A requirement to clean (wash) and sanitize hands before glove use to reduce pathogens on hands

&#;    Manager training to enable visual monitoring of food handler tasks requiring separation of raw and RTE food handling

&#;    This provides managers with a corrective action step to instruct the employee to stop food handling and induce a clean/sanitize procedure of surfaces when gloves are improperly used, which induces food handlers to always wear proper gloves.

&#;    Monitoring can consist of determining numbers of gloves utilized by food handlers per unit time or glove discards in trash receptacles.[12,13]

&#;    Compliance with this cross-contamination prevention can quickly be measured via third-party audits and via self-assessment systems like process HACCP.[41&#;43]

&#;    Food handler training to include the practice of wearing the color-indicator gloves and to remove the gloves before they touch other surfaces or differentfood (which includes a handwash step between switching tasks)

&#;    Job aids to reinforce the proper glove use according to the glove-use management system (Figure 3)

The Value Proposition for Retail Foodservice and Sales Businesses Using Gloves
Reducing the risk of a foodborne disease outbreak due to improper glove use can occur when only a single glove color is used to handle all foods (RTE and raw proteins) as well as all other tasks such as handling and emptying trash, cleaning equipment and facilities, cleaning rest rooms, washing dishes, cleaning up bodily fluids, etc. Managing proper glove use lets employees see (i.e., your food safety culture) gloves as a means to protect foods from cross-contamination.

Implementing and using a glove-use FSMS will change the business&#;s food safety culture within a retail sales or foodservice business by establishing the proper perspective of cross-contamination prevention by food handlers when wearing gloves (e.g., recognizing when hands are probably contaminated and what not to touch when gloved hands are contaminated with raw animal protein).

Improved health department compliance occurs where gloves are required by state food code rules. The majority of the 50 states have adopted, and now enforce, the or later FDA Food Code. The FDA Food Code requires gloves to be used by food handlers when preparing RTE foods.

Another value of implementing a glove-use management system is that the enhancement of compliance to prevent cross-contamination can be more easily monitored (by observations of proper glove use) by management and observed during health department inspections. For example, a manager or a health inspector can quickly see if a food handler is handling food safely while watching food prep and glove use (including handwashing most importantly before but also after gloves are used).

Customer experience can be enhanced in retail foodservice establishments where customers see food preparation by food handlers (e.g., the business can promote its food safety program showing how they use different-colored gloves to handle raw and RTE foods). This promotes customer understanding of how a retail establishment ensures raw food soils and associated contamination are &#;contained in the kitchen or back of the house.&#;   

The authors would like to thank Lynda Ronaldson and Steve Ardagh of the glove company Eagle Protect PBC for their support in the collection of some of the raw scientific information and data analysis related to glove cross-contamination as a contributing factor in foodborne illness outbreaks.

Hal King, Ph.D., is CEO, Public Health Innovations LLC, www.publichealthinnovations.biz, and a member of the Editorial Advisory Board of Food Safety Magazine. He can be reached at . Barry Michaels, B.Sc., is an independent consultant and a partner in the B. Michaels Group Inc., an international scientific consultancy organization.

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(Hoboken, NJ: John Wiley & Sons, ).
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26. Thimothe, J, et al. . &#;Detection of Listeria in Crawfish Processing Plants and in Raw, Whole Crawfish and Processed Crawfish (Procambarus spp.).&#; J Food Prot 65(11):&#;.
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35. Lin, CM, et al. . &#;Comparison of Hand Washing Techniques to Remove Escherichia coli and Calicivirus Under Natural or Artificial Fingernails.&#; J Food Prot 66(12):&#;.
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37. Wallemacq, PE, et al. . &#;Permeability of 13 Different Gloves to 13 Cytotoxic Agents under Controlled Dynamic Conditions.&#; Am J Health Syst Pharm 63(6):547&#;556.
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39. www.food-safety.com/magazine-archive1/augustseptember-/understanding-the-glove-risk-paradigm-part-ii/.
40. Michaels, B. . &#;Gloves: There&#;s More to It At Hand.&#; Food Quality Magazine Feb./March :71&#;75.
41. King, CH. Food Safety Management: Implementing a Food Safety Program in a Food Retail Business (Springer, ).
42. www.fda.gov/downloads/Food/GuidanceRegulation/HACCP/UCM.pdf.
43. www.food-safety.com/magazine-archive1/februarymarch-/implementing-active-managerial-control-principles-in-a-retail-food-business/.


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