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aseptic sterilization

Aaron Hubbard, Thomas Reodl, Ada Hui, Stephanie Knueppel, Kirk Eppler, Siegfried Lehnert, Yuh-Fun Maa
A monoclonal antibody drug product (DP) manufacturing process was transferred to a different production site, where aseptic filling took place within an isolator that was sanitized using vapor phase hydrogen peroxide (VPHP). A quality-by-design approach was applied for study design to understand the impact of VPHP uptake in the isolator on DP quality. A combination of small-scale and manufacturing-scale studies was performed to evaluate the sensitivity of the monoclonal antibody to hydrogen peroxide (H2O2) as well as VPHP uptake mechanisms during the filling process...
March 15, 2018: PDA Journal of Pharmaceutical Science and Technology
Benjamin E Sherlock, Jenna N Harvestine, Debika Mitra, Anne Haudenschild, Jerry Hu, Kyriacos A Athanasiou, J Kent Leach, Laura Marcu
We investigate the use of a fiber-based, multispectral fluorescence lifetime imaging (FLIm) system to nondestructively monitor changes in mechanical properties of collagen hydrogels caused by controlled application of widely used cross-linking agents, glutaraldehyde (GTA) and ribose. Postcross-linking, fluorescence lifetime images are acquired prior to the hydrogels being processed by rheological or tensile testing to directly probe gel mechanical properties. To preserve the sterility of the ribose-treated gels, FLIm is performed inside a biosafety cabinet (BSC)...
March 2018: Journal of Biomedical Optics
B A Timmins, C Thomas Riché, M W Saint-Jean, J Tuck, L Merry
AIM: To describe the facilitators and barriers for nurses to perform quality wound care in three surgical wards of a hospital in Port-au-Prince, Haiti. BACKGROUND: Up to a quarter of patients in low- and middle-income countries may acquire at least one infection while hospitalized. There is a paucity of research investigating nursing wound care practices in low- and middle-income countries regarding the prevention of hospital-acquired infections. METHODS: The design was qualitative descriptive...
February 13, 2018: International Nursing Review
Rinda Devi Bachu, Marina Stepanski, Rami M Alzhrani, Rose Jung, Sai H S Boddu
PURPOSE: The purpose of this study was to develop and evaluate a novel dexamethasone- and tobramycin-loaded microemulsion for its potential for treating anterior segment eye infections. METHODS: The microemulsion was evaluated for pH, particle size, zeta potential, light transmittance, morphology, and in vitro drug release. Sterility of the microemulsion was evaluated by direct as well as plate inoculation methods. Anti-inflammatory activity of dexamethasone, bactericidal activity of tobramycin, and cytotoxicity of the microemulsion were assessed and compared to that of the marketed eye drop suspension (Tobradex®)...
February 6, 2018: Journal of Ocular Pharmacology and Therapeutics
Nomal Chintan Sheth, Yogesh V Rathod, Pratima R Shenoi, Deepa D Shori, Rajiv T Khode, Amruta P Khadse
Background: A novel technique of sterilization of endodontic files is introduced in this article. Aims: Newly introduced sterilization unit, named "SteriFast" is compared with autoclave and glass bead sterilizer using biological indicator. Materials and Methods: Spore strips of Bacillus pumilus were cultured in nutrient broth. This cultured media was used to contaminate the experimental samples of endodontic files. These contaminated files were sterilized using three different techniques...
September 2017: Journal of Conservative Dentistry: JCD
Sujeesh Sebastian, Rajesh Malhotra, Vishnubhatla Sreenivas, Arti Kapil, Rama Chaudhry, Benu Dhawan
INTRODUCTION: Accurate and prompt microbiological diagnosis of prosthetic joint infection (PJI) is crucial for successful antimicrobial treatment. Studies have shown the diagnostic utility of sonication of explanted implants in total joint arthroplasty but all did not use consensus statements for defining PJI. We evaluated the diagnostic utility of culture of samples obtained by sonication of explanted implants compared with periprosthetic tissue cultures (PTC) for the diagnosis of PJI using Musculoskeletal Infection Society (MSIS) consensus criteria...
January 31, 2018: Journal of Microbiological Methods
G K Walker, S Jalukar, J Brake
Hatching eggs collected from resident broiler breeders at 48 wk of age were used to produce male and female chicks that were assigned sex separately to 96 new litter pens and fed either a 0 or 50 g/MT RFC (refined functional carbohydrate feed additive derived from yeast) diet. There were 24 replicate pens of 12 broilers each per diet per sex. Feed intake and BW were determined at 14, 28, and 42 d of age. Litter was sampled by pen using sterile socks at 35 d and tested for Salmonella spp. using an enzyme linked fluorescence assay method...
January 18, 2018: Poultry Science
Louis L Huang, Ellen Ramas, Priti Prasad, Jenny Catania, Pauline Meade, Eamonn Butler, Lawrence P McMahon
There is a paucity of data on the sterility of peritoneal dialysis fluid (PDF) after drug admixture. International Society for Peritoneal Dialysis (ISPD) guidelines suggest using sterile technique when admixing antibiotics; however, the degree of sterility remains unclear. This issue is most pertinent when preparing take-home PDF for outpatient treatment of peritonitis. This study compares the sterility of PDF admixed with antibiotics using a non-touch aseptic technique (NTAT) versus sterile technique.Groups of 8 PDF mixtures (1...
January 2018: Peritoneal Dialysis International: Journal of the International Society for Peritoneal Dialysis
K Fayman, A Allan, C Hudson, M Logarta
BACKGROUND: Neuraxial analgesia during labour is a mainstay of anaesthetic practice globally. Despite the potential for significant neurological and infectious complications, international antisepsis practices for neuraxial anaesthesia vary widely. AIMS: The primary aim of this study was to clarify international antisepsis practices prior to neuraxial analgesia in labour. The secondary aim was to determine an approximate international incidence of neuraxial infections and neurological complications secondary to neuraxial analgesia techniques in labour...
October 6, 2017: International Journal of Obstetric Anesthesia
Jack T Seki, Tian Q Wang, Paul M Yip, Tony Mazzulli, Mark D Minden
Background Dysfunctional central venous catheter prohibits the administration of potential life-saving chemotherapy and the delivery of essential supportive care needs to patients. Sodium bicarbonate injection has been shown to impede against fibrin clot formation and prolong prothrombin time and thrombin clotting time. Sodium bicarbonate injection has been tried as a second-line agent with good results in a small number of patients (internal data not published) when alteplase failed. We assessed whether the pre-filled sodium bicarbonate injection in 5 mL syringes would not only preserve sterility and retain its pH and concentration but also amount to the potential cost savings for future use when stored in a refrigerated environment...
January 1, 2017: Journal of Oncology Pharmacy Practice
Edward T Van Matre, Kang C Ho, Clark Lyda, Beth A Fullmer, Alan R Oldland, Tyree H Kiser
Objective: The objective of this study was to evaluate the stability of epinephrine hydrochloride in 0.9% sodium chloride in polyvinyl chloride bags for up to 60 days. Methods: Dilutions of epinephrine hydrochloride to concentrations of 16 and 64 µg/mL were performed under aseptic conditions. The bags were then placed into ultraviolet light-blocking bags and stored at room temperature (23°C-25°C) or under refrigeration (3°C-5°C). Three samples of each preparation and storage environment were analyzed on days 0, 30, 45, and 60...
September 2017: Hospital Pharmacy
Brian Petrovsky, Eric Monnet
OBJECTIVE: To determine the efficacy of repeated decontamination and sterilization of a disposable port intended for 1-time use during single-incision laparoscopy. STUDY DESIGN: Experimental; prospective, controlled design. METHODS: Six single-access ports used 4 times and 6 single-access ports used 8 times to perform various clean, minimally invasive surgeries were evaluated. Ports were decontaminated in an enzymatic cleaner (dilution, 3:100) and cleaned with a scrub brush for 5 minutes...
December 8, 2017: Veterinary Surgery: VS
Thomas Göbel, Jutta Rauen-Vossloh, Hubert Georg Hotz, Andree Boldt, Andreas Erhardt
A 24-year old woman with a history of Crohn's disease developed bloody diarrhea and multiple abdominal abscesses, daily fever, leukocytosis, and elevated CRP several months after her immunosuppressive therapy with azathioprine was stopped. Recurrent abscess punctures did not detect any pathogenic germs and neither clinical nor serological response was achieved by administration of different antimicrobial therapies. Additionally, new splenic abscesses arose despite ongoing therapy. Under the suspicion of the rare aseptic abscess syndrome, representing an auto-inflammatory, extra-intestinal manifestation of Crohn's disease, the antimicrobial therapy was stopped and an intravenous therapy with prednisolone was initiated...
December 2017: Zeitschrift Für Gastroenterologie
Dominic Anto, Raju Paul Manjooran, Rajeev Aravindakshan, Kumar Lakshman, Raymond Morris
Context: Decompressive craniectomy followed by cranioplasty (CP) uses autologous craniectomy flaps or synthetic materials like titanium. Sterilization and preservation methods for the autologous bone flaps continue to be the surgeon's choice. Aim: This study aimed to assess the short-term as well as long-term clinical outcomes of CP using autoclaved autologous bone grafts. Settings and Design: This retrospective observational study was performed on patients admitted in a tertiary care teaching neurosurgery department...
October 2017: Journal of Neurosciences in Rural Practice
Vladimir Isachenko, Plamen Todorov, Akerke Seisenbayeva, Yerzhan Toishibekov, Evgenia Isachenko, Gohar Rahimi, Peter Mallmann, Dolores Foth, Markus Merzenich
In fact, a full sterilization of commercially-produced liquid nitrogen contaminated with different pathogens is not possible. The aim of this study was to compare the viability of human pronuclear oocytes subjected to cooling by direct submerging of open carrier in liquid nitrogen versus submerging in clean liquid air (aseptic system). One- and three-pronuclei stage embryos (n = 444) were cryopreserved by direct plunging into liquid nitrogen (vitrified) in ethylene glycol (15%), dimethylsulphoxide (15%) and 0...
February 2018: Cryobiology
Dinah J Gould, Jane Chudleigh, Edward Purssell, Clare Hawker, Sarah Gaze, Deborah James, Mary Lynch, Nicola Pope, Nicholas Drey
BACKGROUND: In many countries, aseptic procedures are undertaken by nurses in the general ward setting, but variation in practice has been reported, and evidence indicates that the principles underpinning aseptic technique are not well understood. METHODS: A survey was conducted, employing a brief, purpose-designed, self-reported questionnaire. RESULTS: The response rate was 72%. Of those responding, 65% of nurses described aseptic technique in terms of the procedure used to undertake it, and 46% understood the principles of asepsis...
November 21, 2017: American Journal of Infection Control
Hilton Deeth
Extended shelf-life (ESL) or ultra-pasteurized milk is produced by thermal processing using conditions between those used for traditional high-temperature, short-time (HTST) pasteurization and those used for ultra-high-temperature (UHT) sterilization. It should have a refrigerated shelf-life of more than 30 days. To achieve this, the thermal processing has to be quite intense. The challenge is to produce a product that has high bacteriological quality and safety but also very good organoleptic characteristics...
November 20, 2017: Foods (Basel, Switzerland)
Adeel Ahmad, Anam Wasim, Shahida Hussain, Muhammad Saeed, Bilal Munir Ahmad, Khalil Ur Rehman
Objective: To determine neonatal congenital hypothyroidism among neonates born in a tertiary care hospital of Lahore Pakistan. Methods: This cross-sectional study was carried out at Pathology Department of Allama Iqbal Medical College, Lahore in collaboration with Pediatrics and Gynecology & Obstetrics Department, Jinnah Hospital, Lahore Pakistan. A total of 770 babies were included in this study, both male and female. About 2 ml venous blood samples were collected aseptically from the neonates in sterile clotted tube...
September 2017: Pakistan Journal of Medical Sciences Quarterly
Michiaki Takagi, Yuya Takakubo, Jukka Pajarinen, Yasushi Naganuma, Hiroharu Oki, Masahiro Maruyama, Stuart B Goodman
The innate immune sensors, Toll-like receptors (TLRs) and nucleotide-binding oligomerization domain (NOD)-like receptors (NLRs), can recognize not only exogenous pathogen-associated molecular patterns (PAMPs), but also endogenous molecules created upon tissue injury, sterile inflammation, and degeneration. Endogenous ligands are called damage-associated molecular patterns (DAMPs), and include endogenous molecules released from activated and necrotic cells as well as damaged extracellular matrix. TLRs and NLRs can interact with various ligands derived from PAMPs and DAMPs, leading to activation and/or modulation of intracellular signalling pathways...
July 2017: Journal of Orthopaedic Translation
Mohammed Alshehri, Hamad Albaqiah
AIM: The aim of this in vitro study was to assess the antimicrobial efficacy of materials (gutta percha [GP], polytetrafluoroethylene [PTFE] tape, and vinyl polysiloxane [VP]) used for sealing the implant abutment screw hole (IASH). METHODS: Sixty implants with a Morse cone connection were used. The implants were randomly divided into 3 groups (20 implants/group). In groups 1, 2, and 3, the IASH was sealed with GP, PTFE, and VP, respectively. Unstimulated whole saliva (UWS) was used as a contaminant medium for the incubation of the specimens...
December 2017: Implant Dentistry
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