Aurigene Pharmaceutical Servicesは、高活性薬理物質（HPAPI）の開発と製造（最大OEL 0.1µg /m³）で20年以上の経験を持っています。 開発初期段階から商用生産まで多数のプロジェクトを手掛けており、弊社サイエンティスト、毒性、規制および分析の専門家チームが、世界中のクライアントの要件を的確に満たすべく従事しています。
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At APSL classification of HPAPI molecules is done based on the risk assessment process which is a scientific approach by which potential exposure risk is assessed adequately and the appropriate control strategies is applied. The classification standard is a stepwise process on how to perform a risk-based safety assessment while handling potent compounds, how to determine whether the exposure risk is managed appropriately, and which options are available when selecting exposure controls. Assessments are performed on a case-by-case basis where the greatest exposure risk is given the highest priority.
Performance Based-Exposure Controls Limits
The performance-based approach is predicated by the inextricable association of two components: A hazard classification scheme used to assign compounds into one of a series of health hazard categories of increasing severity based on their inherent pharmacological and toxicological properties, and applying risk based corresponding predefined strategies known to provide the necessary degree of control to employees and the environment for compounds in those categories.
Table 1: PB-ECL Categorization
|Environment criteria||PB-ECL Band|
|OEL (if known) microg/m3||1000 or More||100 - 999||10 – 99||1 - 9||< 1.0|
|Acute Toxicity||Low||Moderate||High||Extreme||Highly extreme|
|Severity of acute (life threatening) effects||Negligible||Low||Moderate||High||Extreme|
|Sensitization||Not a sensitizer||Slight cutaneous allergic reaction||Moderate/strong cutaneous reaction (Skin effect)||moderate to strong respiratory allergic reactions (Skin contact or inhalation)||Extreme Sensitizer|
|Mutagenicity||Negative||Negative||Positive in some||Mutagenic in||Mutagenic in|
|in vitro assays, not confirmed in vivo||most relevant in vivo and in vitro Assays (heritable genetic damage)||most cases|
|Carcinogenicity||Negative||Negative||Some evidence in animals (limited evidence)||Confirmed animal and human (Inhalation)||Carcinogenic|
|Reversibility||Readily Reversible||Readily Reversible||Moderately Reversible||Slowly reversible||Irreversible|
Table 2: Exposure potential evaluation
|Qty of Mat. Handled||DUSTINESS POTENTIAL|
|Low (< 1Kg )||EP1||EP1||EP1||EP2||EP2||EP3|
|High (>10 Kgs)||EP2||EP3||EP3||EP4||EP3||EP4|
New product development shall involve handling of high potent API drug substances at different stages with different concentration levels and physical forms. Such drugs being highly potent and cytotoxic in nature, the open handling of active drug substance or drug product can be a threat to the human and environment. With various options available for containment at source and considering the flexibility required during operations it is a critical to decide containment strategy. This decision must be balanced between control by design (engineering control) and procedural control without compromising on personnel safety, product quality, and process requirements, to provide a system that will meet the current and anticipated future needs for the facility. Choice of handling method will greatly influence system performance and design. Hence a containment control strategy is developed based on the various parameters affecting selection of containment system and standard established guidelines for the same. All state-of-the-art technology shall be reviewed to contain product and avoid human exposure. Different technological applications shall be evaluated to ensure containment expectation are met. This would include the sophisticated technology such as containment at source using split valves, alpha beta port technology isolator, cRABs (Closed restricted access barriers), Biosafety / Cytosafety cabinet / Fume hood etc. Process for defining a control strategy and selection of appropriate containment systems is covered in the subsequent sections of this document.
In practice, containment is a term used for providing engineering controls to achieve all the three namely
Product Transfer operations involving hazardous material present a hazard to the operator. A suitable containment system will be selected at each operating steps that will reduce the level of exposure to below a safe, acceptable limit. Degree to which operators may be exposed to and harmed by release of hazardous materials during product handling operations depends on four main factors, namely:-
Physical form of the material
Exposure could be a result of direct contact with:-
Critical factors for Risk Assessment Process of handling HPAPI handling are:
a) Material form (Dustiness Potential)
|Low||Pellet like, non-friable solids|
|Medium||Granular or crystalline, visible dust, settles quickly|
|High||Fine light powders with dust cloud potential|
b) Duration of Task
Short term –A task duration of < 30 minutes is considered to be short
Long term ->30 minutes or longer
c) Scale of operation
|Lab < 1 Kg(solids)||Small|
|Transfers in range 1- 10 Kg(solids)||Medium|
|Large Scales production transfers- > 10 kg (solids )||Large|
Our HPAPI facilities are equipped with instruments like HPLCs, GC, FTIR, TOC, auto-titratator, Dissolution tester with auto sampler.
QC offers the following facilitates
APSL can handle molecules of OEL up to 0.1 μg/m3Protecting environment, people & product.
HPAPI development and manufacturing (OEL: 1-5)
|Phase||Development/PoC||Pre-clinical/NGMP||Early Phase||Late Phase||Commercial|
|Facility||Hyderabad||Hyderabad||Hyderabad Vizag||Hyderabad Vizag||Hyderabad Vizag|
|Capacity||Lab||Lab||~20 Lts to 2000 L||~160 L – 2000 L||~160 Lt to 2000|
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