ORIGINAL RESEARCH ARTICLE | Jan. 30, 2016
Statistical Process Control in the Evaluation of Microbiological Surface Cleanliness Quality and Spotting the Defects in Clean Area of Pharmaceutical Manufacturing Facility
Mostafa Essam Eissa, Ahmed Mohamed Mahmoud, Ahmed Saber Nouby
Page no 1-17 |
10.36348/sjls
Regular environmental monitoring (EM) system is indispensable routine activity in assessing the
microbiological quality of the manufacturing environment surfaces for the production of medicinal products. However,
the release of the full potential of such regular activity will not be achieved nor the elucidation for points of defects and
improvements cannot be appropriately investigated unless systematic analysis of the results can be ensured and
performed periodically. In the current study, statistical process control (SPC) and six sigma tools were used in the study
of the quality of microbiological surface cleanliness in clean rooms in pharmaceutical manufacturing plant during ten
months period on weekly basis using contact plates. Initial evaluation of data distribution showed that ten out of 11
partitions of the manufacturing area followed distributions other than the Gaussian ones which required logarithmic
transformation to approach normalization for further statistical analysis. When control charts were constructed for
transformed data, material followed by personnel airlocks showed the greatest risk of microbial excursions then the
corridor with the overall risk of failure 99.5% suggesting that there was a state of significant imbalance between cleaning
program and its frequency with the work type and load in these sections. The present work provided insight for the area
of defects that could not be observed using conventional data trending and provided focus on defined sections that could
impact the overall microbiological quality. This analysis provided a promising mean for designing quantitative risk
assessment for microbiological quality control in pharmaceutical, human consumables manufacturing and other
healthcare industries.
ORIGINAL RESEARCH ARTICLE | Jan. 30, 2016
Evaluation of Stroke Preventive Activity of Hugonia mystax Extract in Rats
Abdul Mukit Barbhuiya, S. Sindhura, N. Chenna Keshavulu
Page no 18-29 |
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A stroke is the rapid loss of brain functions due to disturbance in the blood supply to the brain. In the last few
years a great deal of research has been carried out to find the effectiveness of herbal drug for the treatment of stroke.
Both thrombolytic and neuro-protective properties of herbal drugs may be a novel strategy for effective stroke
therapeutics. The animals were divided into five groups of six each. Except the normal and control groups, all other test
groups received different doses of aqueous extract of Hugonia mystax orally for 45 days as per the treatment
schedule.Animals were observed for behavioral parameters after 24 hours of surgery in three different areas,
neuromuscular function, vestibule motor function, and complex neuromotor function which consists of various subtests
such as forelimb flexion, twisting, resistance to lateral push, circling, hind limb placement, forelimb placement, pinna
reflexes and corneal reflexes.The remaining animals in each group were also sacrificed after 72 hours post-surgery by
cervical decapitation. The brains were excised and used for the estimation of Lipid peroxidation, Superoxide Dismutase
and Catalase.Hugonia mystax, a rich source of antioxidant consists of dietary fibers, flavonoids, proteins, vitamins like
vitamin B1 and minerals like iron, copper, magnesium and potassium. It is also an excellent source of molybdenum and
folate. The present study results support that Hugonia mystax has dose dependent stroke preventive activity in common
carotid artery occlusion along with ferric chloride induced thrombosis model.
SHORT COMMUNICATION | Jan. 30, 2016
Chemoinformatics: The stakeholder of Information Solutions for Chemical and Allied Medical Domain
P. K. Paul l, R.K. Sinha, J.Ganguly, D.K. Bhattacharya, M. Ghosh
Page no 30-33 |
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Chemoinformatics or Cheminformatics is an important interdisciplinary field that integrate the domain of
chemistry and information science with computer science. In other words, it is the application and integration of
Informatics with chemical Science. This concept originated some years back but gained popularity as a knowledge
domain in the domain of chemical sciences very recently. It plays a vital role in storing large data sets related to chemical
science and converting or transforming it into knowledge to make better and faster decision. Here, the methods or
algorithm incorporated into it,assist the professionals to identify the better and appropriate chemical compound to also
meet the need of medical and allied domain as they are the ultimate end users of the end product of chemical science.
Inspite of having several benefits, there are so many misconceptions are still there with Chemoinformatics. This paper
explains the general role of Chemoinformatics, its application, brief evaluation and future potentials.
ORIGINAL RESEARCH ARTICLE | March 30, 2016
Anti-arthritic activity of leaves and oil of Aquilaria agallocha
Habibur Rahman, M. Chinna Eswaraiah, A. M. Dutta
Page no 34-43 |
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The present study conducted for Aquilaria agallocha of family Thymelaeaceae for anti-arthritic activity. The
ethanolic extract of Aquilaria agallocha (EEAA) leaves and the Aquilaria agallocha oil (AAO) from Heart Wood were
studied using in-vitro BSA denaturation method and in-vivo Freund's adjuvant induced arthritic rat model. The inhibition
of protein denaturation in-vitro model and paw volume, hematological parameters and radiology of hind legs were
studied. EEAA (100, 250 and 500 µg/ml) showed 34.09%, 36.95% and 43.13% inhibition respectively and AAO (100,
250 and 500 µg/ml) showed 23.68%, 48.21% and 56.71% inhibition of protein denaturation respectively and are
comparable with Diclofenac (100, 250 and 500 µg/ml) showed 39.58%, 75.83% and 77.51% . In FA Arthritic model
EEAA (200 mg/kg and 400 mg/kg) inhibited the increase in paw volume and maximum inhibition were 21.20% and
25.34% respectably on 21th day. The percentage of inhibition was found gradually increasing with the day of treatment.
Treated group with AAO (125 mg/kg and 250 mg/kg) inhibited the increase in paw volume and maximum inhibition
were 19.78% and 27.88% respectably on 13th and 21th day respectably. Further the hematological and radiological also
studies revealed the antiarthritic activity of EEAA and AAO.
ORIGINAL RESEARCH ARTICLE | March 30, 2016
Kinetic evidence for improved invertase activity from a novel mutant of Candida fermentati DMS-4
Sikander Ali, M. Umer Hayyat, Rashid Mehmood
Page no 44-50 |
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Candida fermentati SA3-7, a haploid yeast strain was treated by ultraviolet (UV) radiations and Dimethyl
sulphonate (DMS) for enhanced invertase (EC 3.2.1.26) production. The UV induced mutagenesis did not produce any
stable mutant with improved enzyme production. The culture was subjected to DMS treatment. The mutant DMS-4
obtained after exposure with 0.06 mg/ml of DMS for 45 min gave many fold increased enzyme production (34.12 U/ml)
compared to the wild. After optimization of incubation time (48 h), sucrose concentration (5 g/l), initial pH (6.0) and
inoculum size (2 % v/v, 16 h old), the enzyme production reached 45.65 U/ml with a remarkable >40 fold enhancement.
On the basis of kinetic parameters markedly Qp (0.872 U/g/h), Yp/s (2.403 U/g) and qp (0.209 U/g yeast cells/h), it was
concluded that the mutant was a hyper producer of enzyme and has a faster growth rate. The rate of volumetric
production was 25 fold improved over the parental strain. The enhancement in the enzyme production is highly
significant (HS, LSD 0.045, p≤0.05).
ORIGINAL RESEARCH ARTICLE | March 30, 2016
Control Chart Model for Assessment of Water Quality of a Tropical RiverKshipra Ujjain, India
Shivi Bhasin, Arvind N. Shukla, Sharad Shrivastava, Uttama Mishra
Page no 51-64 |
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The present study involves assessment of water quality of Kshipra river by use of control chart, water quality
index (WQI), physico-chemical and microbiological analysis. Samples were collected from five sites of the river for a
period of one year. The main purpose of the study is to provide a baseline data regarding pollution control, management
and improvement of water quality of this river before Mahakumbh 2016. Analysis of various parameters like dissolved
oxygen (DO), chemical oxygen demand (COD), biological oxygen demand (BOD), total coliform (TC), fecal coliform
(FC), turbidity, transparency, total alkalinity, total hardness, chloride, calcium was performed.WQI values ranged from
284.0-1112.34 and shows all study site to be under pollution stress. Results of the present investigation showed that
water quality of the river is more deteriorated during summer followed by monsoon and winter season. Control chart
model is applied for the first time in the analysis of water quality, as it provides a clear pictorial view about the pollution
status of the river. The sample mean values in control chart cross lower and upper limits consistently in all seasons and at
all study site, indicating very poor water quality. Higher pollution load was observed in Ramghat followed by
Managalnath, Triveni, Mahidpur and Kshipra village study sites. According to CPCB water of Kshipra river is found to
be of D class and river is observed to be under great pollution stress. Immediate remedial measures are recommended to
control pollution and improve water quality of the river which is important for proper management and conservation of
this holy river.