Pharmaceutical Regulatory Affairs: Open Access

The gases plasma from several different gases has shown a sporicidal activity. From these gases, nitrogen gas was most difficult to produce atomic nitrogen radicals. However, these radicals have a high energy, indicating that nitrogen gas plasma could be used to sterilize microorganisms and inactivate endotoxins and lipid A. The sterilization mechanism of nitrogen gas plasma may be the synergistic effect of free radicals such as (OH radical and NO radical) and metastables (N2 or O2 metastable). Thus, the target microorganisms such as bioburden were damaged by degradation, which resulted in death. The biological indicator BI used in this study was Geobacillus stearothermophilus ATCC 7953 at an initial population of 106 CFU/carrier. Sterility assurance level (SAL) of 10-6 was confirmed by using the BI. In addition endotoxins were successfully inactivated by nitrogen gas plasma expossure. More than 5 log reduction of endotoxins could be attained within 30 minutes of nitrogen gas plasma exposure. Lipid A degradation by nitrogen gas plasma exposure was confirmed by LC-MS-MS. Material/functional compatibility was also maintained by nitrogen gas plasma exposure due to shallower penetration depth of 10-20 nm. No deterioration of polymers could be observed by nitrogen gas plasma exposure. Residual gases, if any, are non-toxic. From the above description, it can be said that nitrogen gas plasma sterilization is an alternative future sterilization method.

Introduction: The pharmacy education environment of a developing country like Pakistan is on course of development. Progress was made in 2004 to incorporate the courses of clinical pharmacy in the Doctor of Pharmacy (Pharm.D) degree with a health care insight. Failure to develop a teaching workforce prior to initiation of the above said plan rendered clinical pharmacy to be taught by non-clinical pharmacy professionals who have impinged the course throughout country’s pharmacy academia. They assume the foreign qualified clinical pharmacy professionals as a professional threat.

Methods: A retrospective study was conducted in Pharmacy teaching universities of Karachi, Pakistan. Data of the last 10 years of different pharmacy teaching institutes in Karachi, Pakistan was sought.

Results: A total of 4 private and 1 public university data was available which showed that the total number of qualified clinical pharmacists increased from 2 in 2004 to 3 in 2004 and remained at 4 till 2011, the highest number of clinical pharmacists were seen teaching in pharmacy institute were 7 in the year 2012. However the number again dropped to 6 in 2013 and to just 1 in 2014. All of them reasoned the pharmaco-political situation of the country’s pharmacy education.

Conclusion: The study highlights the current dilemma of the brain drain of clinical pharmacy professionals from the pharmacy education environment of the country and is a wakeup call for the Pharmacy Council of Pakistan (PCP) and the Higher Education Commission (HEC) to formulate legislations and guidelines in the said regard.

In the existing sterilization procedures, it is quite hard or impossible to achieve sterility assurance level (SAL) of 10^-6 and material/functional compatibility simultaneously. Simultaneous achievement of both is required in ISO 14161 and sterilization validation. As gas plasma sterilization penetration was quite shallow at around 10-20 nm level from the surface, so it can kill only one layer of bioburden and can maintain material and functional compatibility in success without any difficulties. Bioburden means sort and number of viable microorganisms in/or the products. It is so-called contaminant. Sterilization was finished in success but material was damaged and useless, such a phenomenon must be avoided. In the current sterilizations, gamma-ray irradiation, electron-beam irradiation, autoclaving, dry heating, hydrogen peroxide gas or ethylene oxide gas sterilization has inferiority not to obtain material and functional compatibility. If gas plasma sterilization will be applicable to the real healthcare products, simultaneous achievement of SAL of 10^-6 and material/functional compatibility can attain without any difficulties, at that time simultaneous achievement is addressed to the existing sterilization procedures and sterilization validation. In that means gas plasma sterilization is the future promise sterilization procedure because only gas plasma sterilization can achieve both in success.

Background: Dendritic cell (DC)-based vaccination is considered to be a potentially effective therapeutic strategy against advanced cancer. The aim of this study was to address the smoking history that might affect the preparation of DC vaccines in validated instructional manufacture.

Materials and Methods: Data on mature DCs generated from 102 sessions of leukapheresis performed on 92 patients with advanced cancer or sarcoma were retrospectively evaluated and compared in relation to the data between their smoking history and the generation of DCs from these patients. 61 patients with adenocarcinoma, including 7 with lung, 10 with breast, 8 with stomach, 12 with colorectal, and 23 with pancreatic adenocarcinoma were enrolled.

Results: The average yield of autologous DCs (15.5 ± 8.3x107) was thought to be dependent on the number of monocytes (124.2 ± 74.1x107) collected by leukapheresis. The average ratio of DCs/apheresed monocytes (DC/aM ratio) was lower in the smoker group (11.1 ± 7.2%) than that in the non-smoker group (17.2 ± 9.3%, p=0.001). The number of DCs and the DC/aM ratio were lower in the patients with gastric and pancreatic cancer than in those with adenocarcinoma of other sites.

Conclusions: As cancer therapy moves forward into the field of persona

Background: Globally, the administration of vaccines by pharmacists is gaining momentum and incorporation of vaccination and injection skills in pharmacy school curricula is becoming more common.

Objectives: This paper reports on one of four focus groups conducted to validate an Australian developed undergraduate vaccination training program (VTP) and its wider application beyond the Australian health care environment.

Methods: A focus group discussion was conducted with six Sri Lankan medical and pharmacist experts following the development of a vaccination training program.

Results: Participants voiced that prior to incorporation of the VTP into undergraduate Sri Lankan curricula, approval should be sought from the Ministry of Health and established vaccinators. The issue of certificates of competency was deemed inappropriate to be issued to Sri Lankan students. Additionally the assessment of competency was seen to be essential on a yearly basis throughout the curricula. Concern was expressed concerning the management of vaccine associated anaphylaxis in the context of minimal pre-hospital care. Participants voiced that vaccination training should be piloted prior to formal incorporation into Sri Lankan undergraduate pharmacy curricula

Conclusion: While there is wide interest in the introduction of clinical skills into pharmacy curricula, the results of this study raise questions about the inclusion of injection and vaccination training in Sri Lankan undergraduate curricula.