Thursday 5 April 2012

ANALYTICAL SERVICES from TEENABIOLABS

Greetings from TEENA BIOLABS !!

Teena Biolabs Pvt Ltd is a Government Approved / USFDA Inspected / NABL Accredited (Certificate No: T- 2851/2852) Contract Testing Laboratory,  providing analytical services for Pharmaceutical industry in the areas of Chemical, Instrumentation,Microbiological and Biological studies.We are one of the leading Analytical laboratories in India, providing analytical  services to various pharmaceutical giants like Aurobindo, DrReddys, Gland Pharma, Granules, Hetero, Cipla, Lupin, Bharat Serums,  etc...

We provide Method Development/Method Validation/Stability studies services to our clients.
We also undertake all type of complete analysis or Individual test analysis of Pharma Raw material (API) /Finished products /Excipent Analysis/Packaging material as per Pharmacopoeia (IP/USP/BP/EP) or Customer Testing Procedures.

  We are equipped with extensive range of analytical tools to support the work undertaken by our professionals.Laboratory Information Management Software (LIMS) deployed to  automize the Lab activities in turn increases the efficiency and quality and overall customer satisfaction.
Our lab is networked with FDA compliant Lab Solutions client/server network environment.

Our highly skilled analysts evaluate and assure the quality of Raw Materials, In-process & Finished products in laboratories fully equipped with modern and sophisticated analytical instruments such as ICP-MS, GC-MS, XRD, DSC, TGA, ICP-OES, PSD, TOC, HPLC, GC, FTIR, and UV-Vis etc.

Teena Bio Labs offers a wide range of tests on all types of waters (Raw water/DM water/WFI Water/Potable Water ..) meeting National and International requirements.

Certifications &Registrations :
USFDA Inspected
PIC/S UKRAINE Audited
NABL Accredited
ISO 9001:2008
CPCSEA registered


Services we offer:

Chemical Analysis

Instrumentational Analysis

Microbiological Analysis

Biological Analysis

PreClinical Services 

Our expertise

* Analytical Method Development/Validations 
(by HPLC/GC/ICP-OES/PSD/STERILITY​/MLT​ & BET)
* Extractable & leachable (E/L) studies
* Physical Charecterization (XRD /DSC /TGA)
* Stability/Photo Stability Studies (RT, ACL, Stress and Protocol Design)
*Trace Metal Analysis ( ICP-MS/ICP-OES)
* Residual Genotoxic  impurity studies (GC-MS / LC-MS)
* Complete Analysis for Raw materials/Finished products as per IP/BP/USP/IH
* Excepients analysis for Sodium Alginate,Polysorbate,Macrogols,Povidone,HPMC,MCCP,​Steric Palmic acid & ​Alcohol content​s​ etc.
​* Identification C in Iron Sucrose ​Inj.
* Stability /Photo Stability Studies
* Forced Degradation Studies
* LBPC's
* Ethylene Oxide & Ethylene Chloro Hydrins Testing
* Viscosity
* Heparins Sodium Analysis
* Microbial Analysis
* Environmental Monitoring
* Preservative Efficacy Testing
* Disinfectant Efficacy Testing
* Preservative Efficacy Testing
* Biological Assays
* Biological Reactivity Testing
* Biocompatibility Studies
* Gas Analysis
* Pre-Clinical Toxicology Studies (Mice,Guinia Pig, Rat & Rabbits)
​Pyrogen, Abnormal Toxicity studies​
* ​Water Analysis for Raw/DM/Portable/WFI
* Seasonal Water Validations
​* TOC Analysis​
* Packaging Material Analysis


Chemical Analysis

The Chemical Analysis is of two categories:
A) QUALITATIVE ANALYSIS :

B) QUANTITATIVE ANALYSIS:

Instrumental Analysis

ICP-OES
FULLY AUTOMATED INSTRUMENTATION LIKE..
1. HPLC Shimadzu (Isocratic & Gradient)
2. GC-HSS (Agilent)/GC-TCD(Shimadzu)
3. FTIR (Bruker)
4. Polarimeter
5. Dissolution Test Apparatus -Electro labs
6. AAS
7. UV-Vis Spectrophotometer & other lab equipments.
8. Particle Size Analyzer (PSD) by Malvern,UK.
9. ICP-OES spectro meter for Elemental Analysis by Perkin Emler
10.  Liquid Borne Particle Counter (LBPC)
Particle size Analysis
11. Air borne particle counter
12.KTA -Lonza
13. Viscometer

14. ICP -MS (Agilent)
15. GC -MS (Shimadzu)
16. XRD (Pan Analytica)
17. DSC (Shimadzu)
18. TGA (Shimadzu)


Microbiological

Sterility Testing
Microbiology is the study of living organisms of microscopic; like bacteria, fungi, protozoa & viruses to some extent. Some micro organisms are beneficial (involved in making Yogurt, production of penicillin, Interferon & alcohol) while some are detrimental (i.e., causes diseases in Humans and Animals).
There are different areas where microbiology plays a crucial role. The importance of Microbiology in pharmaceutical industries is , For any Pharmaceutical, the environment in which the processing takes place are in controlled environment. The numbers of micro-organisms present are restricted. This is possible by installing Air Handling Units with Hepa Filters. These filters, filter the air entering into the room , the number of viable & non-viable particles are reduced. Since HEPA filters produce unidirectional air the chance of cross contamination is minimized
The common tests undertaken in the Microbiological Laboratory:
1. Microbial Limit Test
MLT
2. Assay of Antibiotics
3. Assay of Vitamins
4. Sterility Test by Membrane method
5. Sterility Test by Direct Inoculation
6. Bacterial Endotoxins (BET) Qualitative/Quantitative
7. Assay of Lactic Acid Bacillus, etc.
8. Water Contamination
9. Food Contamination
10. Drug Contamination

Biological Analysis

Pyrogen Test
BIOLOGICAL TESTS AND DETERMINATIONS
Biological Assays:
Follicle Stimulating Hormone (FSH) Assay
Luteinizing Hormone (LH) Assay
Residual Luteinizing Activity Test
Chorionic Gonadotropin (HCG) Assay
Menotropin (HMG) Assay
Urofollitropin (FSH) Assay
Corticotropin (ACTH) Assay
Vasopressin Assay
Oxytocin Identification Test
BioAssay
Pancreas Provocation Test
Estrogenic Activity
Acute Toxicity
Safety Testing
Absorption from Injection Site
Enzyme Linked Immunosorbent Assay (ELISA)
Pyrogen Testing
Heparin/Enaxoparin Studies
Anti-Factor Xa Activity Test
Anti-Factor IIa Assay

Local Tolerence studies
Primary Skin IrritationDermal Sensitization
Safety Pharmacology
Reproductive Toxicity
Eye Irritation / Corrosion

PreClinical Services 

We offer all the services in the Preclinical Area. We conduct studies to determine the efficacy and toxicity of the test compounds
The following studies are undertaken at our facility.
- Acute Toxicology
- Repeated Dose / Sub-Acute Toxicology studies
- Sub Chronic Studies
- Chronic Studies
- Reproductive & Developmental Toxicity
- Local Toxicity studies
- Allerginicity / Hypersensitivity studies

Thanks & Regards,

Meenakshi Namala
Phone: + 91-9701888454
mail: meenakshi@teenalabs.com


Laboratory: Teena Biolabs Pvt. Ltd.
Plot No. 41, S.V.Co-operative Industrial Estate,
Bachupally (V) , Quthbullapur(M), R.R.Dist.
Hyderabad, Telangana, India. -500 090
Website: www.teenabiolabs.com

Corp Office: #906, 9th Floor,
Manjeera Trinity Corporate
JNTU-HITEC City Road,
KPHB IIIrd Phase,
Kukatpally, Hyderabad, Telangana, India.- 500 072.
Phone: + 91-40-66668027, 66665808
Email Us: admin@teenalabs.com

No comments:

Post a Comment