SWAB MATERIALS FOR CLEANING VERIFICATION

Seminar on SWAB MATERIALS FOR CLEANING VERIFICATION : 

Seminar on SWAB MATERIALS FOR CLEANING VERIFICATION Presented by, U.PAVANI , M. Pharmacy (1st sem),Industrial Pharmacy,St. Peter’s institute of pharmaceutical sciences, Vidyanagar,Hanamkonda,wgl.

Contents : 

Contents Introduction Swab characterization Swab test in cleaning validation Cotton swab Other swabs Conclusion References

Introduction : 

Introduction Swab means: A small piece of cotton that is used to apply medication/ cleanse a wound or obtain a specimen of a secretion. In medicine, a cotton swab is a small piece of material, such as gauze or cotton, which is used to clean wounds, apply medications, or retrieve samples of body fluids such as blood or mucus. Swabs may be attached to stiff wires or sticks used for cleansing or applying medicine.

Slide 4: 

Swab characterization: Natural or synthetic cotton wool, glass wool, synthetic fabric, and filter paper are commonly used as the carrier for removing the contaminant from the equipment surface. The selection of the best swab material is guide by physical as well as chemical criteria, with the objective having, 1.With no previous treatment, 2.Good physical removal properties, 3.Least significant chemical background contribution.

Slide 5: 

The selection of swab material is based on following criteria 1. swab absorption capacity 2.Swab material must have a solvent absorption capacity sufficient to be moistened or saturated in order to add a solubilization effect to the physical removal process. Swab sampling: A swab sampling is a fibrous material that used to wipe a surface to remove residues from the surface. Typically, the swab is textile fabric of some kind attached to a suitable handle. The swab head is typically wetted with a solvent( water, organic solvent mixture) and then is wiped across a fixed area of validated for the residue determination to be made.

Slide 6: 

Choosing the Correct Swab for Cleaning Validation: During the manufacture of pharmaceutical and biotechnology products, care must be taken to ensure that these products are not contaminated either by the previous manufacturing run or by the cleaning process itself. The cleaning process can be validated by sampling various parts of the manufacturing equipment and analyzing the sampling material for contaminants.

Slide 7: 

Cleaning residue can be eluted from the swab and analyzed using standard analytical techniques such as HPLC or gas chromatography. Recently, total organic carbon (TOC) has been gaining favor as the analytical method of choice because it is a sensitive technique that will measure all oxidizable carbon compounds, regardless of organic functional groups. Three of the most important criteria for choosing a swab for cleaning validation include:

Slide 8: 

Minimal Background— Background is the amount of contaminant on a swab measured by the analytical technique after testing has been performed according to the analytical protocol before sampling. Blank contribution from the swab must be minimal. High Recovery Rate— Recovery means the percentage of contaminant actually measured by the analytical technique when the swab is spiked with a known quantity of that species. Sixty-percent recovery rates are acceptable; however, higher recovery rates are desirable. Low Particle Generation—It is critical that the swabbing material leave the swabbed surface free from particles which would further contaminate the surface.

Swab test in cleaning validation : 

The advantages of the swab method is truly a surface sampling method. Insoluble compounds, based-on residues or that cannot be easily removed via a rinsing solution, can be measured using the swab method. Swab test in cleaning validation

Measuring system : 

Measuring system TOC with SSM-5000A TOC series contains a cell that consists of a long and a short cell. The long cell is typically used for water analysis and the short cell for solid sample analysis. In order to attain a higher sensitivity for the analysis of solids, the solid sample module can also be connected to the long, and therefore, more sensitive measuring cell. This way the system can be easily be used in cleaning validation without sacrificing the flexibility of easy switching between water and solid sample analysis modes.

Cotton swab : 

Cotton swab Background: A cotton swab is a short spindle with one or both ends coated with an absorbent cotton padding. Such swabs have long been used for various cosmetic and personal hygiene tasks, particularly for cleaning the ear. The cotton swab was invented in the 1920s by a Polish-born American named Leo Gerstenzang. In 1926, he changed the name to Q-Tips Baby Gays, claiming that the "Q" stand for quality. Eventually, Baby Gays was dropped from the name and the swabs became known simply as Q-Tips.

Slide 12: 

Construction: The traditional cotton swab has a single tip on a wooden handle, and these are still often used, especially in medical settings. They are usually relatively long, about six inches (15 cm ). The advantage of the paper sleeve and the wooden handle is that the package can be autoclaved to be sterilized (plastic sleeves or handles would melt in the autoclave). Cotton swabs produced for home use are usually shorter, about three inches (7.6 cm) long, and usually double-tipped. The handles were first made of wood, then made of rolled paper, which is still most common (although tubular plastic is becoming popular).

Slide 13: 

swabs used to apply color cosmetics can be made with special flocked tips made of non-woven fibers. In addition to personal care, swabs are used for industrial purposes. For example, long handled wooden swabs are designed for sampling microbiological cultures. Other industrial swabs may be specially designed for cleaning electronic parts. Raw Materials: There are three primary components involved in swab manufacture: 1)The spindle or stick, which forms the body of the swab. 2) The absorbent material coated onto the spindle ends. 3)The package used to contain the swabs.

: 

2300 2301 2313 . All cotton swabs are tightly wrapped, pre-cleaned cotton ensuring the least amount of extractable contaminants. Wooden handles (2300, 2301) offer aggressive cleaning while pointed tip (2313) allows for precision cleaning

Slide 15: 

Spindle: Spindles can be sticks made of wood, rolled paper, or extruded plastic. They can be made to different specifications depending on the intended use. Personal care products are fairly small and lightweight and are only about 75 mm long. Swabs made for industrial use may be more than twice as long and are typically made of wood for greater rigidity

Slide 16: 

Absorbent end material: Cotton is most often used as an end covering for swabs because of its absorbent properties, fiber strength, and low cost. Blends of cotton with other fibrous materials may also be used. Packaging: Packaging requirements vary depending on the application for the swab. Some personal hygiene swabs, like Q-tips, are packaged in a clear plastic shell (known as a blister pack) which is attached to a fiberboard backing.

The Manufacturing Process : 

The Manufacturing Process Different methods are used in swab manufacture depending on the design of the swab. In general the process can be described in three major steps: 1) spindle fabrication, 2) cotton application, and 3) packaging of the finished swabs. Spindle fabrication Spindles are made several ways depending on their material of composition. Paper spindles are made by die-cutting a heavy grade paper and then tightly rolling the paper to form a stick. Plastic spindles are made by an extrusion molding process. In this case, the plastic resin and other additives are blended together, heated, and extruded through a die.

Slide 18: 

After manufacture, the spindles are loaded into a hopper on the manufacturing line in preparation for cotton application. Cotton application A hopper full of spindles is vibrated to cause them to fall through a long, thin slot at the bottom of the hopper and onto a rotary stick carrier. As the wheel moves the sticks along, they contact a rotating friction wheel that rubs against the swab spindles causing them to spin. The carrier advances the sticks through a glue pot station where adhesive is applied to the opposite ends of the sticks. The cotton then adheres to the spindle is wound tightly by the spinning sticks. Approximately 0.05-0.1 g of cotton has been deposited on the spindle.

Slide 19: 

The ends of the swabs then pass through a series of narrow channels while they are still spinning. These channels compress and shape the cotton on the end of the stick and give it a smooth shape. Packaging The finished swabs pass through a counting wheel, as the swabs are counted, they are pushed up against an inclined plane. It sends a signal to a piston arrangement, which slides the group of swabs onto a paper divider. The divider and the swabs are then dropped into the plastic package. In subsequent operations, a paperboard backing is glued over the filled plastic container and the entire assembly is packed for shipping.

Slide 20: 

Quality control The spindles must be checked to ensure they are straight and free of imperfections, such as stress cracks or other molding defects. The cotton used to coat the ends must be of specific purity, softness, and fiber length. swabs used for biological purposes must remain sterile until used. Usage The most common use for cotton swabs is to clean the ear canal or to remove earwax. Medical-type swabs are often used to take microbiological cultures. They are swabbed onto or into the infected area, then wiped across the culture medium. Cotton swabs are also often used as an applicator for various cosmetics, ointments, and other substances.

Slide 21: 

Swabs with sponge/foam heads are widely used for industrial applications. ATP-free swabs were developed to facilitate the technique in non microbiological hygiene tests. RNase and DNase free swabs allowed better recovery of nucleic acids for forensic molecular techniques. They are also used to take DNA samples from, most commonly, the inner cheek. They can be used to apply medicine to a targeted area, to selectively remove substances from a targeted area, or to apply cleaning substances like Butadiene.

The Future for cotton swab : 

The Future for cotton swab Future developments in swab technology may play a role in space technology as well. The Micro Clean Company, under a technology license from National Aeronautics and Space Administration (NASA), has recently perfected the first cotton swab that has the absorption qualities of cotton yet meets NASA's requirement for clean room use.

Slide 23: 

Pocket Swab Plus The PocketSwab Plus provides a true measure of ‘hygiene’ and ‘cleanliness’ by detecting both microorganisms and food/organic product residues present on surfaces. PocketSwab Plus APPLICATIONS Food Beverage Critical Care Pharmaceutical Cosmetics Personal Care Products Medical Device Clean Room Water Treatment Environmental

Micro tube body swab handle : 

Micro tube body swab handle

Slide 26: 

Specifications Device Length ( inches) 7.75 (20 cm) handle length (inches) 2.75 (7 cm) Swab Length ( inches) 6 (15 cm) Swab Tip Foam tipped with large surface area for sample capture Write on label Yes Stability prior to activation after 6 hours swabbing Storage 2 - 25°C Reaction Visibility yes Metal Detectable yes

Head Foam Swabs : 

Head Foam Swabs Cleantex CT 707 A Rectangular Head Foam Swab: The Rectangular Head Foam Swab is a large, general purpose swab for cleaning surfaces and hard to reach areas. I t is a closed-cell polyurethane foam head possesses excellent durability and cushioning. A rigid internal paddle provides reliable support. The large polypropylene handle, measuring 41/4 inches, enables good control and ease of use. Used for: • Cleaning with solvents such as Isopropyl alcohol• A pplying lubricants and other liquids• Removing excess materials• Scrubbing applications

Swabs for Cleaning Fiber Optics Interfaces : 

Swabs for Cleaning Fiber Optics Interfaces Computer scientists are well aware of the emerging importance of fiber optics (“light pipes”) for communication. Contamination at fiber optics interfaces can cause significant transmission losses. To prevent this, tighter mechanical and optical specifications for fiber optics are being instituted that require even greater attention to cleaning. Ultraclean swabs are often selected to clean the interfaces. Swab fibers in contact with the surface to be cleaned.

Slide 29: 

The fibers may engulf the contaminants, perhaps with the help of a cleaning liquid. A wet swab will be more effective at removing material than a dry swab. The wetting liquid may also extract contaminants from the swab head, if it is not clean. solutions contain water, surfactants, and organic solvents(e.g., alcohol). The swab must be compatible with the cleaning solution. For fiber optics, wiping with a swab is effective way to particulate contaminants and can also help remove molecular contaminants, especially with the aid of solvents. Example of a swab used for fiber optic cleaning

NASOPHARYNGEAL SWAB FOR DETECTION OF RESPIRATORY INFECTIONS : 

NASOPHARYNGEAL SWAB FOR DETECTION OF RESPIRATORY INFECTIONS Nasopharyngeal swabs are the preferred specimens for respiratory virus rapid antigen testing and pertussis testing. The swab inserted into the nasopharynx Measure the distance from the corner of the nose to the front of the ear and insert the shaft only half this length. In adults, this distance is usually about 4 cm, (finest thickness of this swab shaft ).

Slide 31: 

Tilt the patient’s head back slightly to straighten the passage from the front of the nose to the nasopharynx to make insertion of the swab easier. Rotate the swab several times to enlarge the epithelial cells, and then remove the swab. Put the NP swab into the transport medium and break it at the score mark on the shaft so that it does not protrude above the rim of the container. Failure to do so will result in the transport medium leaking and the sample being discarded.

Conclusion : 

Conclusion Now a days swabs are most commonly used for cleaning purposes. Some swabs are used in diagnostic purposes.

References : 

References Jenkins, K.M., Vanderwielin, A.J., Armstrong, J.A., Leonard, L.M., Murphy, G.P., and Piros, N.A., “Application of Total Organic Carbon Analysis to Cleaning Validation,” PDA Journal of Pharmaceutical Science & Technology, Vol. 50, No. 1, 1996, pp. 6–15. "http://en.wikipedia.org/wiki/Swab"Categories D.W. Cooper, “Using Swabs for Cleaning Validation: A Review,” Cleaning Validation (Institute of Validation Technology, Royal Palm Beach, Florida, USA, 1997). M.A. Strege et al., “Total Organic Carbon Analysis of Swab Samples for the Cleaning Validation of Bioprocess Fermentation Equipment,” BioPharm 9(4), 42–45 (1996).

Slide 34: 

"Cotton Swab", Earwax, American Academy of Otolaryngology — Head and Neck Surgery, 2008, http://www.entnet.org/HealthInformation/earwax.cfm. "Health Canada to review cotton swab labelling", CBC.ca, 2008-02-06, http://www.cbc.ca/canada/story/2008/02/06/swab-warning.html. "Cotton Swab", Q-tips History, Unilever Home and Personal Care, 2007-2008, http://www.qtips.com/history.php Schueller, Randy (1996), "Cotton Swab", History, FindArticles.com, http://findarticles.com/p/articles/mi_gx5205/is_1996/ai_n19124735    K.M. Jenkins and A.J. Vanderwielin, “Cleaning Validation: An Overall Perspective,” Pharm. Tech. 18(4), 60–73 (1994).

THANK U : 

THANK U