"Identification of Essential Assessment Criteria in Facial Botulinum Toxin Injections".

INTRODUCTION: Facial botulinum toxin injections represent the most commonly performed aesthetic non-surgical procedures by plastic surgeons; however, post-graduate programs remain devoid of objective tools to adequately assess competence in trainees. In this study, the authors employ the Delphi methodology to establish a list of essential assessment criteria in facial botulinum toxin injections. METHODS: A list of 10 suggested criteria was generated through a literature search and in consultation with an expert plastic surgeon. A panel of content experts was selected to which an online survey was administered; skills were ranked for their relevance using a 1-10 Likert scale. Recommendations for additional skills were solicited and survey rounds were repeated until consensus was achieved. The latter was a measure of panelist reliability and assessed using Cronbach α (≥0.8); skills with a rating of 7 or above were taken to be essential. RESULTS: The survey process was successful at achieving consensus following two rounds of survey administration. Twenty-one participants completed the first round representing a response rate of 38%. Percent agreement among the panel was 83% and Cronbach α was computed as 0.78, necessitating further rounds. The response rate in the second round was 90%; one additional skill was added; percent agreement and Cronbach α improved to 88% and 0.87, respectively. CONCLUSION: Nine assessment criteria were identified as essential in facial botulinum toxin injections; these findings provide the groundwork necessary for the development of an objective assessment tool for the more appropriate training of marginalized aesthetic procedures in plastic surgery.

Assessing baseline knowledge and practices of injection safety among primary health care workers in Cross River State, Nigeria: a cross-sectional urban-rural comparative study.

INTRODUCTION: unsafe injection practices are commonplace in low-income countries, and place health care workers at risk of blood-borne infections. A safe injection strategy requires a synchronized approach to deal with change in behavior of users and service providers towards safer practice. There is general lack of data on injection safety practices in Cross River State. This was a baseline study to compare the knowledge and practice of safe injection practices among primary health care (PHC) workers in urban and rural health facilities in Cross River State, Nigeria. METHODS: this was a cross-sectional comparative study among PHC workers in randomly selected rural and urban Local Government Areas (LGAs). Using multistage sampling technique, a total of 320 respondents: 160 from the urban LGAs and 160 from the rural LGAs were interviewed. Semi-structured interviewer administered questionnaires were used to obtain data. Data analysis was done using STATATM version 14.0. Associations were tested using Chi square, and multivariate logistic regression analysis. RESULTS: in this study, there was no difference in the baseline knowledge (58.8% vs. 55.0%, P=0.499) and practice (33.1% vs. 34.4%, P=0.813) of injection safety between PHC workers in the urban and rural locations. In the multivariate logistic regression model, the senior health workers had a two-fold increased odds of practicing safe injection compared to their junior counterparts [OR=2.21 (95% CI: 1.28,3.84)]. CONCLUSION: in both the urban and rural locations, there was good knowledge but poor practice of injection safety among respondents in the LGAs; hence, the need to organize periodic injection safety training and retraining of PHC workers targeting junior workers to improve on the practices of injection safety.

Intraoperative local injection of uterosacral ligaments with ropivacaine during uterine surgery: A systematic review and meta-analysis of randomized controlled trials.

AIM: To perform a systematic review and meta-analysis of all randomized controlled trials that examined the efficacy of intraoperative local injection of the uterosacral ligaments with ropivacaine on postoperative pain and opioids consumption in patients undergoing uterine surgery for hysterectomy/myomectomy. METHODS: PubMed, Scopus, Web of Science and Cochrane Library databases were screened from inception to September 5th, 2020. We appraised the risk of bias using the Cochrane's risk of bias tool. Resting postoperative pain scores and cumulative consumption of postoperative opioids were regarded as continuous data, analyzed using the inverse variance method and reported as standardized mean difference (SMD) and weighted mean difference (MD), respectively, with 95 % confidence intervals (95 % CIs). RESULTS: Five studies met the inclusion criteria comprising 230 patients (117 and 113 patients received ropivacaine and placebo, respectively). The studies had an overall low risk of bias. Resting postoperative pain scores were not significantly different between both groups at 2 h (SMD = -0.30, 95 % CI [-0.70, 0.11], p = 0.15), 12 h (SMD = 0.04, 95 % CI [-0.26, 0.37], p = 0.81) and 24 h (SMD = -0.06, 95 % CI [-0.32, 0.20], p = 0.68). However, the ropivacaine group had significantly reduced cumulative opioid consumption during the first 24 h postoperatively (MD = -9.07, 95 % CI [-14.47, -3.66], p = 0.001). CONCLUSION: Intraoperative local infiltration of uterosacral ligaments with ropivacaine is technically feasible and significantly reduces postoperative opioid consumption in women undergoing gynecologic surgery of the uterus.

Injectable medications: self-reported practices of nursing professionals. / Práticas de medicações injetáveis: conduta referida de profissionais de enfermagem.

OBJECTIVE: To identify the self-reported injectable medications of nursing professionals in the state of São Paulo. METHOD: Survey study that assessed the self-reported frequency of injection medications through a validated electronic questionnaire, applied from September to December 2017. RESULTS: The 1,295 computed responses showed non-compliances such as sharing multidose vials for two or more patients (10.8%), reusing single-use supplies, such as use of saline flush syringes for different patients (1.2%) and needle recapping after use (4.9%). Greater adherence to glove use for administration of intravenous injections (80.5%) and lack of training for handling safety devices (13%) were reported. Correlational data showed that, the older the age, the better the self-reported injecting practices. CONCLUSION: Although most practices are within Safe Injecting practices, there are reports of risky practices, such as sharing single-use supplies. Training for the use of safety devices is not yet a reality for all professionals, since many reported it as rare.

Intrajejunal vs oral levodopa-carbidopa therapy in Parkinson disease: A retrospective cohort study.

Levodopa-carbidopa intestinal gel (LCIG) is a method of continuous administration of levodopa - the standard treatment in Parkinson disease (PD, a neurodegenerative disorder characterized by resting tremor, rigidity, gait impairment, and bradykinesia), thought to reduce the short-life and pulsatile problems of oral administration. We aimed to study the effects of Levodopa-Carbidopa therapy in 2 separate groups: one with intrajejunal administration of Levodopa-Carbidopa gel and the second with oral therapy.We performed an observational retrospective Romanian cohort study on 61 patients diagnosed with PD patients, with Hoehn and Jahr 3 and 4 stages, recruited from a single regional tertiary center in Cluj-Napoca, Romania, between 2009 and 2019.The mean adjusted UPDRS III (and similarly for UPDRS II) improved in the LCIG compared to the oral therapy group with 15.6 (95% CI 12.0-19.2, P < .001), and with 18.4 (95% CI 13.8-22.9, P < .001), stratified for the Hoehn and Jahr stages 3 and 4. There was a 41.7% (10) reduction in dyskinesia, and 29.2% reduction in wearing off/on-off at 1 year in the LCIG group compared to 0% (0) dyskinesia reduction, and 2.7% reduction in wearing off/on-off in the oral therapy group.Continuous intrajejunal infusion of LCIG ensures a significant and clinical reduction in motor fluctuations compared to oral therapy in advanced PD, even after adjustment for important confounders.

Improving injection safety practices of Cambodian healthcare workers through training.

BACKGROUND: This study evaluated the impact of a safe injection safety training on healthcare worker (HCW) practice and knowledge following an HIV outbreak in Roka commune, Cambodia. METHODS: Surveys were conducted at baseline (September 2016) and seven months after a training intervention (March 2018) using the World Health Organization standardized injection practices assessment tool. HCWs were sampled at 15 purposively government health facilities in two provinces. HCWs were observed during injection practices and interviewed by trained experts from Becton-Dickinson and the Ministry of Health Cambodia. The Rao-Scott chi square test was used test for differences between baseline and follow-up. RESULTS: We completed 115 observations of practice at baseline and 206 at post-training follow-up. The proportion of patients whose identification was confirmed by HCWs prior to procedure being performed increased from 40.4% to 98% (p <0.0001). The proportion of HCWs who practiced correct hand hygiene increased from 22.0% to 80.6% (p = 0.056) [therapeutic observations] and 17.2% to 63.4% (p = 0.0012) [diagnostic observations]. Immediate disposal of sharps by HCWs decreased from 96.5% to 92.5% (p = 0.0030). CONCLUSIONS: We found significant improvements in the practice of patient identity confirmation and hand hygiene but not in the immediate disposal of sharps in the post-training intervention. However, findings are not representative of all HCWs in the country. Further pre-service and in-service training and monitoring are necessary to ensure sustained behavior change.

Experiences With Counterfeit Aesthetic Medical Devices and Injectables: A National Survey.

BACKGROUND: Counterfeit medical devices and injectables have recently garnered interest in the field of aesthetics. Unlike their original counterparts, these counterfeit products have neither been tested nor verified using certified quality control measures. OBJECTIVE: Our study investigated the pervasiveness of counterfeit products in the field as well as the experiences and attitudes of practitioners. MATERIALS AND METHODS: An online survey was distributed to current members of the American Society for Dermatologic Surgery (ASDS) and the American Society for Laser Medicine and Surgery (ASLMS). RESULTS: For medical devices, 37.4% have encountered counterfeits and 20.1% have experienced patients with adverse events from them. For injectables, 41.1% have encountered counterfeits and 39.7% have experienced patients with adverse events from them. Compared with their original, most respondents believe that counterfeits are worse in terms of reliability, safety, and effectiveness. The majority also believe that counterfeits are either very or extremely endangering to patient safety. CONCLUSION: Counterfeit medical devices and injectables are not uncommonly encountered. Overall, practitioners believe counterfeits are endangering patient safety and result in adverse events and think that either stricter rules and regulations or better enforcement of existing regulations is necessary.

Qualification of a chemotherapy-compounding robot.

KIRO® Oncology (Kiro Grifols, Spain) is a robotic system for automated compounding of sterile injectable drugs including intravenous cytotoxic treatments. The present article describes the qualification procedure applied prior to production phases. Peristaltic pumps which ensure the reconstitution of drugs were tested with water and NaCl 0.9%. The performance of the robot (accuracy and precision) to prepare bags, syringes and elastomeric pumps was evaluated with three placebo solutions (aqueous, foaming and viscous) using gravimetric controls. Microbiological controls were also performed. The pumps met the requirements set for volumes ranging from 5 to 100 mL. A total of 274 preparations was compounded. For the bags, the filling accuracy was within the limit of ±10% from 1 to 48 mL with aqueous solution, from 0.6 to 48 mL with foaming solution and from 5 to 48 mL with viscous solution. For all syringes and elastomeric pumps, it was within the limit of ±10%. The precision was validated for all preparations, except for bags and syringes prepared with 0.6 and 0.25 mL, respectively. The samples of surfaces and air complied with ISO 5 class environment. Among the 24 gloves tests performed, two presented microbiological growth. All Media fill tests were validated. The qualification procedure led us to exclude injections of any active principle volume strictly lower than 1 mL. The microbiological contamination of operators' gloves remains a critical point. Our operators will be made aware of the issue during the training period.

Visible Particulate Contamination Control for Injectable Products: A Life-Cycle Approach.

Visible particulate matter contamination is responsible for the rejection or recall of numerous batches of injectable product each year. The result is wasted time, effort, money, product and the limited availability of medically necessary drug and biologic products. Recently published compendial standards have alleviated some of the confusion surrounding suitable test methods and acceptance criteria for visible particulates; however, the complexities of visual inspection methods across a wide range of injectable product types packaged in diverse and sometimes complex container systems has complicated the approach to visible particulate control in injectable products. The solution is a life-cycle approach to visible particulate contamination control that addresses the prevention, inspection, identification, and remediation of visible particulate contamination. More importantly, the life-cycle approach to visible particulate control is aligned with current United States Food and Drug Administration's good manufacturing practices and can serve as an effective tool for demonstrating regulatory compliance for inspections, audits, and regulatory submissions.

Safe injection practices among anesthesia providers: a scoping review protocol.

OBJECTIVE: The objective of this review is to identify and map literature related to safe injection practices among anesthesia providers in developed nations. The mapped literature will be used to determine if there is sufficient literature available to pose specific questions that can be valuably addressed, through a future systematic review, to reduce the prevalence of unsafe injections. INTRODUCTION: A safe injection is one that does not harm the recipient, does not expose the healthcare worker to avoidable risk, and does not result in waste that is a danger to the community. The literature is replete with examples of disease outbreaks connected to unsafe injections via the misuse of syringes, needles and medications. Many such outbreaks involve unsafe injections by anesthesia providers. INCLUSION CRITERIA: This scoping review will consider any research article or policy document, including unpublished reports, that provides information related to safe injection practices by anesthesia providers in developed nations. METHODS: For studies published in English from 2000, the databases to be searched include Ovid MEDLINE, CINAHL and Google Scholar. The search for unpublished literature will include the websites of anesthesia organizations, the Centers for Disease Control and Prevention, and the National Institutes of Health. Results will be screened by two independent reviewers who will use a standardized tool to independently extract data from each included source. The results of the review will be presented as a map of the data extracted in a tabular form and in a narrative descriptive summary.

Best Practices for Aripiprazole Lauroxil Administration: From Formulation Development to Injection Technique.

Long-acting injectable (LAI) antipsychotics are an important treatment option for patients with schizophrenia. Advances and variability in formulation technology have provided several LAI antipsychotic treatment options for schizophrenia, with a wide range of doses and dose intervals. However, clinical reviews of LAIs have not focused on formulation development despite its clinical relevance to injection safety and technique. This article reviews the relationship between formulation technology and clinical practices for LAIs, with a focus on aripiprazole lauroxil, a long-acting atypical antipsychotic indicated for the treatment of schizophrenia. The formulation developed for aripiprazole lauroxil is an aqueous-based suspension suitable for use as a prefilled syringe that, after injection, will release aripiprazole slowly into the plasma. The clinical relationship between the aripiprazole lauroxil formulation and proper injection techniques is explained, including why tapping and shaking the syringe to resuspend the drug particles and rapid injection speed are key steps for best injection practices for this formulation.

Why are so huge differences reported in the occurrence rate of skin lipohypertrophy? Does it depend on method defects or on lack of interest?

Lipohypertophy (LH) is the most common skin complication of incorrect injection technique which does not only represent an aesthetic defect but also severely disrupts insulin pharmacokinetics/pharmacodynamics. As a consequence of that, hormone release is delayed and unexplained/unpredictable hypoglycemia occurs, both deteriorating metabolic control while negatively affecting adherence to treatment and quality of life. The economic burden due to unwanted intra-LH injections is accounted for by inappropriately high insulin requirements, increased emergency-related hospitalizations, and loss of work days. Greater attention has to be paid by diabetes care teams to education programs with periodic refreshers to achieve better metabolic control and reduce the economic burden of diabetes.

Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals.

Vial capping plays a critical role in the drug product manufacturing process owing to the complex interplay of several adjustable process steps. Seal quality and integrity and containment assurance are essential for parenteral pharmaceuticals, as the vial's content may be contaminated or, in the case of highly potent drugs (e.g., antibody drug conjugates), may bear a risk of contamination. The residual seal force (RSF) method can enable further insight in capping equipment settings independently of the container closure system (CCS) and their resulting seal quality.The present study investigates the accuracy of the RSF method focusing on different force settings, RSF development over time, distance between capping plates and vial neck (roller-axis), time point of flip-off button removal, and internal and external vial pressure differences (flight simulation and vials closed under vacuum).Results show that the forces used on an RSF tester should be kept low to minimize CCS deformation, and a period of stable RSF values after the initial decrease should be implemented between capping and RSF measurement to increase accuracy. Variations in the distance between the capping plates and vial neck (roller-axis) can result in incomplete crimps or visual defects of the seals. In addition, the time point of flip-off button removal as part of the sample preparation had no significant impact on RSF measurements. Finally, pressure differences between the vial interior and exterior had no significant impact on the RSF data.LAY ABSTRACT: Vial capping plays a critical role in the drug product manufacturing process due to the complex interplay of several adjustable process steps. Seal quality, integrity, and containment are essential for parenteral pharmaceuticals, as the vial's content varies and may be contaminated, sensitive to stress, and/or highly potent (eg, antibody drug conjugates). The residual seal force (RSF) method can enable further insight in capping equipment settings independently of the container closure system and their resulting seal quality.In this study, we determined RSF values by applying different force settings of the RSF tester and investigated the influence of sample preparation on the determination of RSF. Furthermore, the capping process parameter roller-axis was evaluated by RSF and visual inspection. In addition, we investigated the influence of pressure differences of vials on the RSF as they occurred during air transport and products closed under vacuum.

Achieving "Zero" Defects for Visible Particles in Injectables.

The reduction of visible particles in injectable products is an important element in the consistent delivery of high-quality parenteral products. An important part of this effort is the control of particles that may emanate from the primary packaging materials. The Parenteral Drug Association (PDA), with the support of the Pharmaceutical Manufacturers Forum (PMF), has undertaken the task of developing test methods to assess the cleanliness of primary packaging components used in the manufacturing of sterile injectable products. Further work is focused on end-to-end analysis of the supply chain to identify additional points where particles may enter the finished product workflow. This includes shipment, receipt, transfer, and fill and finishing operations. This information and appropriate corrective actions and control methods, coupled with appropriate patient risk-based acceptance limits, are intended to provide better and more consistent supply of injectable products that meet current compendial and good manufacturing practice (GMP) expectations. Aligning control limits between supplier and pharmaceutical manufacturers will offer further improvement. This paper describes the formation of a task force to address these needs and current progress to date.LAY ABSTRACT: Visible particles must be controlled in parenteral products. Such particles come from many sources including the primary packaging materials. The Parenteral Drug Association (PDA), with the support of the Pharmaceutical Manufacturers Forum (PMF), has formed a task force to review and improve particle measurement methods and perform an end-to-end analysis of how particles may enter into parenteral products. These activities are intended to lead to more consistent control limits for visible particles and ultimately more consistent supply of high quality injectable products.

Conducting Clinical Risk Assessments for Visible Particulate Matter in Parenteral Preparations.

Visible particulate matter in injectables presents one important question for consideration: "What are the potential implications to the patient?" The risks of visible particulate matter to patient safety have been comprehensively reviewed elsewhere. However, the methods used to assess and characterize the risks have been explained with various degrees of specificity and supporting rationale. To date, the assessment process lacks the necessary consensus to permit a more standardized and consistent approach to evaluate the potential patient risks.The purpose of this commentary is to provide one model that might be used to evaluate the three most relevant factors impacting the risk of injections containing particulate matter: the source of the particle, particle-specific attributes, and characteristics of the intended patient population. Each of these factors is considered with a focus on the more important aspects that might be relevant to imposing untoward risk. The discussion also includes the importance of differentiating the concepts of risk assessment from risk acceptance when establishing criticality levels for product attributes.LAY ABSTRACT: Pharmaceutical products intended for injection or infusion may contain particles that can emanate from different sources. Some particles, such as suspensions, are intended. Others are not, and those particles are the subject of rigorous manufacturing process controls to limit their presence and reject units that might contain visible defects. However, no technology exists that can prevent or eliminate all particles from these products. As a result, comprehensive risk assessments must be conducted to identify the capability of manufacturing systems to limit particles and detect and reject atypical units. An essential component of this strategy includes understanding the potential impact that injected or infused particles might have to a patient receiving these medications. The purpose of this paper is to provide one approach that clinicians might use to conduct that risk assessment by discussing the important aspects of the source of the particle, its characteristics (such as size or composition), and the relevant patient factors such as the illness being treated or other medical conditions that might impact the risk to these patients if particles are injected or infused.

A post hoc analysis utilizing the FDA toxicity grading scale to assess injection site adverse events following immunization with the live attenuated Zoster Vaccine (ZVL).

BACKGROUND: ZOSTAVAX (ZVL; Zoster Virus Live), is a single dose, live, attenuated vaccine licensed for the prevention of herpes zoster (HZ) and post herpetic neuralgia (PHN) in adults ≥50 years of age. Injection site adverse events (AEs) of erythema, swelling and pain were solicited within 5 days post vaccination in the 2 pivotal studies of ZVL; ZEST (ZOSTAVAX Efficacy and Safety Trial) and SPS (Shingles Prevention Study). Protocol specified criteria were used to report the frequency and intensity of injection site AEs in ZEST and SPS studies. Subsequently, the FDA Toxicity Grading Scale provided guidance for uniform assessment of AEs across all adult vaccine clinical trials. The objective of this post-hoc analysis was to categorize the previously reported injection site AEs in two pivotal trials of ZVL according to the current FDA Toxicity Grading Scale. METHODS: The current FDA Toxicity Grading Scale provides a measure for classifying injection site AEs by four grades [Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe) and Grade 4 (life threatening)]. Injection site erythema, swelling, and pain intensity gradings were assigned to the respective FDA Toxicity Grade based on this appropriation. A descriptive analysis of the proportion and risk difference (within 95% confidence intervals) of injection site AEs per the FDA Toxicity Grading Scale is provided. RESULTS: The frequency of injection site AEs (erythema, swelling, pain) after subcutaneous vaccination with ZVL were higher in recipients of ZVL compared with placebo. Majority of the injection site AEs observed were Grade 1 (mild) or Grade 2 (moderate) in intensity. Additionally, Grade 3 (severe) injection site AEs were observed infrequently. CONCLUSIONS: Application of the FDA Toxicity Grading Scale provides a uniform AE assessment tool across different adult vaccines. This post hoc summary of injection site AEs using FDA Toxicity Grading Scale provides further evidence of low frequency of severe injection site AEs post ZVL vaccination.

Assessment of safe injection practices in health facilities in Oman.

BACKGROUND: Unsafe injection practices put patients and providers at risk of infectious and noninfectious adverse events. A 2001 Ministry of Health survey on injection practices in Oman indicated that, while overall standards were good, in some areas there was a need for improvement. AIM: We aimed to evaluate injection safety practices to determine whether facilities meet the requirements for practices, equipment, supplies and waste disposal, and to identify unsafe practices. METHODS: We conducted a national cross-sectional survey in 2007 using the World Health Organization tool to evaluate injection safety practices. Using 2-stage cluster sampling, 80 government and 61 private health facilities were randomly selected and evaluated. RESULTS: There was no shortage of injection equipment nor evidence of attempts to sterilize disposable devices. Care providers immediately disposed of the used needle/syringe in sharps containers. Phlebotomy devices were taken from sealed packets in 96% of facilities. In private facilities, 66.3% of the care providers were fully immunized against hepatitis B. Wearing a new pair of gloves for phlebotomy was observed in only 46% of government and 38% of private health facilities. Many health facilities lacked alcohol-based handrub. CONCLUSIONS: Many injection safety aspects were satisfactory. However there are still opportunities for improvement. Actions are required to make alcohol-based handrub and appropriate sharps containers available and to provide hepatitis B vaccine and training to health care workers in all facilities.

Barriers and Facilitators to Injection Safety in Ambulatory Care Settings.

OBJECTIVEIdentify factors referred to as barriers and facilitators that can prevent or assist safe injection practices in ambulatory care settings to guide quality improvement.DESIGNIn this mixed-methods study, we utilized observations and interviews.SETTINGThis study was conducted at ambulatory clinics at a midwestern academic medical center from May through August 2017. Sites included a variety of clinical settings that performed intramuscular, intradermal, intravenous, or intra-articular injections.PARTICIPANTS AND INTERVENTIONSDirect observations of injections and interviews of ambulatory care staff were conducted. An observation checklist was created, including standards of injection safety from nationally recognized guidelines. Interview questions were developed using the System Engineering Initiative for Patient Safety (SEIPS) model. Interviews were recorded, transcribed, and then coded by 2 investigators.RESULTSIn total, 106 observations and 36 interviews were completed at 21 clinics. Injection safety standards with the lowest adherence included using needleless access devices to prepare injections (33%) and the proper use of multidose vials (<80%). Of 819 coded interview segments, 461 (56.3%) were considered facilitators of safe injection practices. The most commonly identified barriers were patient movement during administration, feeling rushed, and inadequate staffing. The most commonly identified facilitators were availability of supplies, experience in the practice area, and availability of safety needles and prefilled syringes.CONCLUSIONSPerceived barriers and facilitators to infection control elements of injection safety are interconnected with SEIPS elements of persons, organizations, technologies, tasks, and environment. Direct observations demonstrated that knowledge of safety injection standards does not necessarily translate to best practices and may not match self-reported data.Infect Control Hosp Epidemiol 2018;39:841-848.

Analysis of Particulate Matter in Liquid-Finished Dosage Forms.

Pharmacopeias recognize particulate matter as a common phenomenon. The current regulatory requirements relating to particulate matter in parenterals state that solutions for injections or infusions are clear and "practically" (or "essentially") free from ("readily detectable") particles when examined under defined conditions of illumination. Pharmaceutical companies are required to know their processes and have them under control. In order to control and reduce the potential influx of particulate matter, Novartis Technical Operations in Unterach developed a particle life-cycle program that involved an establishment of a dedicated particle laboratory operating under clean room conditions. The analytical capabilities of this particle laboratory were crucial for the characterization of particles and supported identification of potential sources of particulate matter. After implementing this program and respective actions, product and process understanding significantly improved. This resulted in a decrease of reject rates, AQL (Acceptable Quality Limit) failures, and corresponding batch rejections, thereby increasing the availability of Novartis products from Unterach for the patients. The main objective of this article is to show the detailed particle characterization approach including Quality by Design (QbD), methods, and equipment. Examples from projects and particulate matter investigations are presented.LAY ABSTRACT: Parenteral formulations should not contain particulate matter. However, as external contamination as well as formation of particles during manufacturing cannot be entirely excluded, pharmaceutical companies use visual inspection and AQLs to monitor occurrence of particles. To ensure patient safety, Novartis Technical Operation in Unterach established a particle-free analytical laboratory with a focus on particle characterization and root cause analysis of particle formation. The ultimate goal is to reduce occurrence of particles in formulations altogether, and increase process understanding. The approach toward particle characterization adopted at Novartis Technical Operations in Unterach is presented in the article.