Surface Of Packaging Materials Research Articles

Developing Acceptable Surface Limits for Occupational Exposure to Pharmaceutical Substances

Abstract Acceptable surface limits (ASLs) are developed in order to establish a quantitative measure for the potential risk from exposure by dermal contact. In the pharmaceuticals industry, ASLs are used for protection against active pharmaceutical ingredients that are known to cause pharmacological or toxicological effects. An ASL can be used, together with appropriate analytical methods and industrial hygiene monitoring, to assess workplaces for potential dermal exposure and to protect the health and safety of individuals who might come in direct contact with contaminated surfaces in the workplace. ASLs are also used to evaluate the adequacy of housekeeping measures and the effectiveness of engineering containment approaches, or to determine whether a chemical is present on surfaces where it is not intended to be (e.g., in lunch rooms or offices, or on the outside surfaces of packaging materials). However, they should not be confused with cleaning limits for the surfaces of manufacturing devices that might come into contact with the drug product, which are set to minimize cross contamination between drug products and to protect end-users (e.g., patients taking drug products) as opposed to workers. A number of parameters must be evaluated in order to accurately develop appropriate and scientifically supportable limits. These include the dose or concentration that will cause the potential effect, the degree of chemical transfer from contaminated surfaces to the skin, and the rate or amount of percutaneous absorption. In practice, this information is usually limited or unavailable. Additionally, there has been very little regulatory guidance on the setting of ASLs. Consequently, in order to calculate an ASL, various assumptions must be made by health and safety professionals regarding how dermal exposures might occur. As quantitative data become available, the ASL can be adjusted accordingly. An overview of the setting of health-based and performance-based ASLs for pharmaceutical substances from animal and human toxicological data is provided.

Photosensitization-based inactivation of food pathogen Listeria monocytogenes in vitro and on the surface of packaging material

The study was focused on the susceptibility of Listeria monocytogenes ATCL3C 7644 cells and biofilms to non-thermal antimicrobial treatment – photosensitization in vitro and after adhesion to the surface of packaging material. L. monocytogenes was incubated with 5-aminolevulinic acid (ALA) (7.5 mM) for 0–2 h and illuminated with visible light. The LED-based light source used for the illumination emitted light λ = 400 nm with energy density 20 mW/cm 2. The illumination time varied 0–20 min, and a total light dose reached 0–24 J/cm 2. The obtained data indicate that L. monocytogenes produces endogenous porphyrins after incubation with 7.5 mM ALA. Subsequent illumination of cells remarkably inactivates (4 log) them in vitro. Photosensitization diminished population of Listeria cells adhered onto the packaging material by 3.7 log and inactivated bacterial biofilms by 3.1 log. It was shown that antimicrobial efficiency of photosensitization depended on the illumination time, incubation with ALA time as well as on the used ALA concentration. In conclusion, cells and biofilms of L. monocytogenes ATCL3C 7644 can be effectively inactivated by ALA-based photosensitization in the solution as well as adhered onto the surface of packaging material. Obtained data support the idea, that photosensitization as non-thermal and effective antimicrobial treatment has potential to develop into environmentally safe, surface decontamination technique.

Inactivation of food pathogenBacillus cereusby photosensitizationin vitroand on the surface of packaging material

The study was focused on the possibility to inactivate food pathogen Bacillus cereus by 5-aminolevulinic acid (ALA) - based photosensitization in vitro and after adhesion on the surface of packaging material. Bacillus cereus was incubated with ALA (3-7.5 mmol l(-1)) for 5-60 min in different environment (PBS, packaging material and wheat grains) and afterwards illuminated with visible light. The light source used for illumination emitted light at lambda = 400 nm with energy density at the position of the cells, 20 mW cm(-2). The illumination time varied from 0 to 20 min, and subsequently a total energy dose was between 0 and 24 J cm(-2). The obtained results indicate that B. cereus after the incubation with 3-7.5 mmol l(-1) ALA produces suitable amounts of endogenous photosensitizers. Following illumination, micro-organism inactivated even by 6.3 log. The inactivation of B. cereus after adhesion on the surface of food packaging by photosensitization reached 4 log. It is important to note that spores of B. cereus were susceptible to this treatment as well; 3.7-log inactivation in vitro and 2.7-log inactivation on the surface of packaging material were achieved at certain experimental conditions. Vegetative cells and spores of Gram-positive food pathogen B. cereus were effectively inactivated by ALA-based photosensitization in vitro. Moreover, the significant inactivation of B. cereus adhered on the surface of packaging material was observed. It was shown that photosensitization-based inactivation of B. cereus depended on the total light dose (illumination time) as well as on the amount of endogenous porphyrins (initial ALA concentration, time of incubation with ALA). Our previous data, as well as the one obtained in this study, support the idea that photosensitization with its high selectivity, antimicrobial efficiency and nonthermal nature could serve in the future for the development of completely safe, nonthermal surface decontamination and food preservation techniques.

Pulsed Light and Pulsed Electric Field for Foods and Eggs

Two new technologies for use in the food industry are described. The first method discussed uses intense pulses of light. This pulsed light (PureBright®) process uses short duration flashes of broad spectrum “white” light to kill all exposed microorganisms, including vegetative bacteria, microbial and fungal spores, viruses, and protozoan oocysts. Each pulse, or flash, of light lasts only a few hundred millionths of a second (i.e., a few hundred microseconds). The intensity of each flash of light is about 20,000 times the intensity of sunlight at the earth's surface. The flashes are typically applied at a rate of about one to tens of flashes per second. For most applications, a few flashes applied in a fraction of a second provide an effective treatment. High microbial kill can be achieved, for example, on the surfaces of packaging materials, on packaging and processing equipment, foods, and medical devices as well as on many other surfaces. In addition, some bulk materials such as water and air that allow penetration of the light can be sterilized. The results of tests to measure the effects of pulsed light on Salmonella enteritiditis on eggs are presented.The second method discussed uses multiple, short duration, high intensity electric field pulses to kill vegetative microorganisms in pumpable products. This pulsed electric field (or CoolPure™) process can be applied at modest temperatures at which no appreciable thermal damage occurs and the original taste, color, texture, and functionality of products can be retained.

Evaluation of Glutaraldehyde and Hydrogen Peroxide for Sanitizing Packaging Materials of Medical Devices in Sterility Testing

External surfaces of packaging materials used for sterile medical devices may introduce contaminants into working areas used for sterility testing. Light wiping with tissues moistened with alkaline 2% glutaraldehyde (Cidex) or 3% hydrogen peroxide effectively reduced counts on 5 X 8 cm strips of packaging material (Tyvek) inoculated with 10(7) spores of Bacillus subtilis. The ability of antimicrobial agents to penetrate packaging material and kill contaminants on the medical device was tested by inoculating filter membranes with ca 100 cells of Pseudomonas aeruginosa or Staphylococcus aureus or ca 100 spores of Bacillus subtilis. A sterile square of test packaging material placed over the inoculated membrane (direct method) or 0.5 cm above the membrane (indirect method) was wiped with the antimicrobial agent. Except for polyethylene film (3 mil), all materials tested, including glassine and several types of coated and uncoated Tyvek, were penetrated by the agents, killing cells on the inoculated membranes. Death rates varied, depending on the organism, packaging material, and testing method. It is suggested that penetration tests be performed before using antimicrobial agents for sanitizing packaging materials during sterility tests.

DESTRUCTION OF BACTERIAL SPORES ON SOLID SURFACES

Heat resistance of bacterial spores is reduced by chemical pretreatment with peracetic acid and hydrogen peroxide. The sporicidal effect of peracetic acid is better than that of hydrogen peroxide. Because of the rapid decomposition at higher temperatures, peracetic acid seems to be suitable as a chemical sterilant at lower temperatures. Additionally, it is removed more efficiently than hydrogen peroxide from the surface of packaging material.

Determination of total migration from plastics-packaging materials into edible fats using a 14C-labelled fat simulant

In the future, total migration may prove to be of great importance in the assessment of the physiological acceptability of new packaging materials, provided a practicable. reliable and sensitive method of determination is available. A suitable radio-tracer method has been developed using a 14C-labelled standard triglyceride mixture, known as fat stimulant HB 307-[14C]. On the basis of the principle proposed by the Bureaux Internationaux Techniques des Matières Plastiques (BITMP), the sample of the packaging material is weighed before and after storage in fat simulant HB 307[14C]. The content of test fat remaining in and on the stored sample is determined by radio-analysis. The total migrate then equals the difference between (a) the weight of the sample before storage in the test fat and (b) the weight after storage less the weight of the fat absorbed by the sample during the storage.This method was tested with specimens of plasticized PVC, LD-polyethylene, polystyrene and polyvinylidene chloride. The coefficient of variation of the single results about the mean showed a marked dependence on the amount of total migrate, the coefficients associated with 1, 6 and 12 mg total migrate/dm 2 surface of packaging material being 9, 2 and 0·6% respectively.

Determination of total migration from plastics-packaging materials into edible fats using a 14C-labelled fat simulant

In the future, total migration may prove to be of great importance in the assessment of the physiological acceptability of new packaging materials, provided a practicable, reliable and sensitive method of determination is available. A suitable radio-tracer method has been developed using a 14C-labelled standard triglyceride mixture, known as fat simulant HB 307-[ 14C]. On the basis of the principle proposed by the Bureaux Internationaux Techniques des Matières Plastiques (BITMP). the sample of the packaging material is weighed before and after storage in fat simulant HB 307-[ 14C]. The content of test fat remaining in and on the stored sample is determined by radio-analysis. The total migrate then equals the difference between (a) the weight of the sample before storage in the test fat and (b) the weight after storage less the weight of the fat absorbed by the sample during that storage. This method was tested with specimens of plasticized PVC, LD-polyethylene, polystyrene and polyvinylidene chloride. The coefficient of variation of the single results about the mean showed a marked dependence on the amount of total migrate, the coefficients associated with 1, 6 and 12 mg total migrate/dm 2 surface of packaging material being 9, 2 and 0·6% respectively.